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CTD Conversion

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.

From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

澳洲幸运5开奖官网开奖正规网址 is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate.  For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.

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Good Manufacturing Practice

Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.

  • Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted.
  • The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.

Medicines Control Council’s (MCC)  general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).

  • Under Section 22C of the Act, all South African manufacturers should be licensed
  • The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers
  • When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved

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Medicines Registration

Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.

A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.

The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.

The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.

Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.

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Submissions Publishing

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.  From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions.  澳洲幸运5开奖官网开奖正规网址 can compile submissions in eCTD format and print in paper format as required by the current MCC requirement. This allows the MAHs to be prepared for future eCTD requirements from MCC and enables efficient electronic submission dossier management.

Registrations and Submissions Information Management

Module 1 (Administrative 1.10 Foreign Regulatory Status) requirement from Medicines Control Council’s (MCC) requires the applicant to provide a list of countries in which an application for the same product is being applied for in South Africa has been submitted, dates of submission (if available). This should detail approvals (with indications).  Applicants must declare whether a marketing application for the medicine has been rejected in the countries listed under 1.10.1 prior to submission of the application in South Africa. If the medicine has been rejected, repeatedly deferred or withdrawn, then the MCC must be informed and the reasons supplied.

If no application has been submitted for registration in the country of origin, include a statement to provide the reason for this decision. It should be noted that aforementioned information is required to be provided in dossier however, it does not mean that this will help to speed up the review process.

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Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL/SPM format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA) and Health Canada. The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated SPM requirements for over 6 types of documents.

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澳洲幸运5开奖官网开奖正规网址 PRISM

Multiple products, multiple markets, combined with varied Regulatory requirements challenge Life Sciences organizations to capture and maintain wide variety of information in order to obtain Health Authority (HA) approvals.

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Global Presence Xtended Global Presence with Local Expertise

Catering to Worldwide Regulatory Requirements with Regional Expertise Across 120+ Countries.

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Regulatory Contract Staffing Services

Agile, Global, Contract Staffing Services for Diverse Regulatory Functions.

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澳洲幸运5开奖官网开奖正规网址 SoMAD

Mergers and Acquisition, Spin-offs, and Divestitures (SoMAD) Consulting services.

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Industries We Serve

Radically redefining the global Regulatory solutions and services landscape for Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies.

  • Pharmaceutical
  • Generics
  • Medical Device
  • Biologics
  • Consumer Healthcare
  • Innovator Drugs

  • CRO

  • CMO

  • Generics

  • USA/Canada

  • Europe

  • Asia Pacific

  • Middle East

  • Latin America

  • Vaccines

  • Biosimilars

  • Cosmetics Regulatory Services

  • Nutraceuticals / Food Supplements

  • OTC Regulatory Services

  • In-country Representation 
  • European Authorized Representative (EAR)
  • US Agent Service
  • Authorized Representative
  • UKRP
  • Swiss CH-REP
  • Device Registration in USA
  • 513(g) Submission
  • FDA 510(k) Consulting & Submission
  • De-Novo Registration of Medical Devices
  • Q-Submission Meeting
  • Premarket Approval
  • RFD and Pre-RFD
  • Device Registration in EU
  • In Vitro Diagnostic Regulation (IVDR)
  • EU MDR
  • Medical Device Registration - RoW Market
  • Medical device Registration – LATAM
  • Device Registrations-SaMD
  • Medical Writing
  • Clinical Evaluation Report (CER)
  • Post Marketing Surveillance Support (PMSS)
  • Performance Evaluation Report (PER)
  • Device Documentation
  • Device Technical File Publishing
  • Medical Device Labeling
  • Medical Devices Artwork Services
  • QMS
  • Quality Management System (QMS) Services
  • ISO 13485:2016 Compliance
  • 21 CFR 820 Compliance
  • Medical Device Single Audit Program (MDSAP)
  • ISO 14971 Risk Management Consulting
  • Design History File
  • Strategy
  • Regulatory Intelligence
  • Regulatory Strategy
  • Regulatory Submission and Registration
  • Staff Augmentation
  • Translation Support
  • Technical Writing
Publishing and Submissions
Regulatory Labeling

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by 澳洲幸运5开奖官网开奖正规网址 team and submitted to the client for finalizing the artwork/ label.

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The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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Global Health Authorities
Regulatory Services

Latest News

  • Dec 26, 2023
    BioSpectrum Published Freyr’s Perspective on the ‘Impact of Artistic Packaging in Pharmaceuticals’
  • Dec 04, 2023
    Suren Dheendayalan, CEO – 澳洲幸运5开奖官网开奖正规网址 Solutions, Clinches 'Compliance and Regulatory Training 2023 Award' at the Pharma L&D and HR Summit
  • Dec 01, 2023
    Drug Discovery Online Published Freyr’s Perspective on Vaccines and FDA Approvals
  • Sep 28, 2023
    澳洲幸运5开奖官网开奖正规网址 Partners with PKG Group LLC for a DMF Submission to USFDA
  • Sep 11, 2023
    BioSpectrum Asia Published Freyr’s Perspective on ‘Regulatory Landscape of In Vitro Fertilisation (IVF) Across Asia’
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Latest Blogs

  • CE Marked Devices and Market Strategies in Great Britain
    Dec 18, 2023
    CE Marked Devices and Market Strategies in Great Britain
  • Verification and Validation Intricacies for Personalized Medical Devices
    Dec 18, 2023
    Verification and Validation Intricacies for Personalized Medical Devices
  • Common Specifications for Medical Devices
    Dec 18, 2023
    Common Specifications for Medical Devices
  • Current Regulatory Scenario for Medical Devices in the UK
    Dec 18, 2023
    Current Regulatory Scenario for Medical Devices in the UK
  • The Art of Risk Management in Pharmaceutical Packaging
    Dec 15, 2023
    The Art of Risk Management in Pharmaceutical Packaging
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Case Studies

  • Promotional Compliance Specialist (Coordinator)
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Webinars

  • Cosmetics Entry in Nigeria: A Regulatory Roadmap
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Newsletter

  • 澳洲幸运5开奖官网开奖正规网址 CONNECT - Volume 10 Issue 4
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Regulatory Radio

  • Season 4 - EU Regulatory Pathways for Biological Products
    Season 4 - EU Regulatory Pathways for Biological Products
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Client Testimonials

Freyr's Regulatory support for eCTD submission is enormous with a specialized tool for publishing and submission, 澳洲幸运5开奖官网开奖正规网址 SUBMIT. In a year long engagement with the organization, we are extremely satisfied with the quality of their work and knowledge of their resources and leadership. 

- Associate Director, Regulatory Technology and Ops,
Global Top 20 Pharmaceutical Company

This has been a large team effort and the continued progress is appreciated. Many thanks to the 澳洲幸运5开奖官网开奖正规网址 team as they were integral over the last few months in helping to reach a critical project milestone. Excellent team work!!

– Program Manager, Global Top 5, $70+ Bn, Pharma & Consumer Healthcare Company

澳洲幸运5开奖官网开奖正规网址 provided critical services to support the CTA approval of one of our Top 3 global oral care brand. The project management and team support was amazing. The quality, quick turnaround time, online submission and validation was remarkable. We successfully got the MHRA approval on the CTA. I want to thank the entire 澳洲幸运5开奖官网开奖正规网址 Team for their role in this.

– Regulatory Affairs Franchise Manager,
Global Top 5 Consumer Healthcare Company

As we near the completion of a major filing, I would like to thank 澳洲幸运5开奖官网开奖正规网址 and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

We recognize and acknowledge the exemplary performance and look forward to working together.

– Manager, Regulatory Operations, Global Top 20, $20+ Bn,
Pharmaceutical Company

澳洲幸运5开奖官网开奖正规网址 provided assistance and the review was conducted thoroughly and rapidly. I also appreciate that the team called me this morning and walk me through the files. It is once again a pleasure working with Freyr.

Just wanted to say that the team are doing a great job. Please keep up the excellent work!

– Product Specialist Global Regulatory Affairs, Global Top 5 Healthcare Company

I would like to thank the 澳洲幸运5开奖官网开奖正规网址 team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

- Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

I would like to thank the entire team for their support for critical XEVMPD compliance activities.

-  Program Manager, Global Top 5 Pharma and Consumer Health Company

Overall the project has gone very well; with targeted submission numbers being achieved substantially ahead of the original plan.

-  Associate Director, Fortune 100, Global Top 5 Consumer Healthcare Company

It has been an absolute pleasure working with 澳洲幸运5开奖官网开奖正规网址 over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

I look forward to returning to work with you in January and an exciting new chapter in our time.

– GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

Thanks for the great work you are doing, sharing the great principles that 澳洲幸运5开奖官网开奖正规网址 uses for its employees and your focus on sustainability.

– Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company

Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

– Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

We would like to congratulate 澳洲幸运5开奖官网开奖正规网址 team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

We are pleased to acknowledge the timely support and recommend 澳洲幸运5开奖官网开奖正规网址 to everyone who are looking for such services.

– Vice President, Clinical Research & Pharmacovigilance, Microlabs

We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

– VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

I approached 澳洲幸运5开奖官网开奖正规网址 with an issue we were having in quickly confirming the global acceptability of several new raw materials for use in our products. Within a few days, their team provided me with a comprehensive review by country citing regulatory references. The reports also included valuable additional information regarding cosmetic uses of the materials in various markets. For a very reasonable price, 澳洲幸运5开奖官网开奖正规网址 was able to provide our company with exactly what we were looking for.

– Director, Regulatory Affairs, US based, Cosmetics Manufacturing Company

On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire 澳洲幸运5开奖官网开奖正规网址 team for partnering in our mission to serve patients.

- Director, Supplier Performance Management, Global Regulatory Affairs & Safety
Forbes Global Top 10 Biopharma Company

Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

-  Senior Regulatory Associate, Worldwide Regulatory Strategy
A leading research-based global Biopharmaceutical Company

澳洲幸运5开奖官网开奖正规网址 was a great find indeed. The 澳洲幸运5开奖官网开奖正规网址 Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets 澳洲幸运5开奖官网开奖正规网址 apart from their competitors. As always, I would recommend 澳洲幸运5开奖官网开奖正规网址 again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

-  Project Manager, A full-service Clinical Research Organization (CRO)
Based in Florida

During the past several years, I’ve had the pleasure of working with 澳洲幸运5开奖官网开奖正规网址 in the publication, validation and electronic submission of regulatory documentation to the US FDA. The 澳洲幸运5开奖官网开奖正规网址 team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

-  President,
An Independent regulatory and quality consulting company

We would like to appreciate 澳洲幸运5开奖官网开奖正规网址 for making us equipped with well-defined deliverables to the FDA. For their demonstration of 5-star support, we will use 澳洲幸运5开奖官网开奖正规网址 for our overflow of work. We truly believe in 澳洲幸运5开奖官网开奖正规网址 as a brand and as an expert provider of Regulatory services and look forward to work together on an on-going basis. 

Terrific Job Freyr, GREAT TEAMWORK!!! 

- Director of Regulatory Affairs-Operations,
India based, Global 4+ Bn Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. 澳洲幸运5开奖官网开奖正规网址 provided dedicated resources needed to meet our immediate regulatory filing requirements. 澳洲幸运5开奖官网开奖正规网址 was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided.

- Quality Control and Regulatory Manager
US based, Global Innovator Products Manufacturer

Collaboration is a working practice whereby individuals work together to a common purpose to achieve business benefit. Collaboration enables individuals to work together to achieve a defined and common business purpose

On behalf of entire team, we would like to Congratulate both of the 澳洲幸运5开奖官网开奖正规网址 resrouces for getting nominated as “Values & Behavior Champion” for Excellent collaborative efforts and hard work while contributing on publishing activities irrespective of external factors influence which created some challenging situations. You guys were extremely productive & did not lose your focus. We appreciate your efforts for championing our organization’s Values & Behaviors and being a Role Model to your team.

- Global Franchise Head – Submissions
Switzerland based, Global Pharmaceutical Company

Thank you so much for the receipt and ACK for this Submission. And thank you and all the 澳洲幸运5开奖官网开奖正规网址 team for all your hard work and long hours in getting this Submission out on time. It is greatly appreciated by everyone.

– US based, Global, full-service clinical research organization

Freyr’s resource has been a great asset to us in ensuring all the target deadlines for numerous submissions were met. The eCTD submissions continued to meet the quality standards. We truly appreciate all the work 澳洲幸运5开奖官网开奖正规网址 has done in the past 3 months. Thank you so much 澳洲幸运5开奖官网开奖正规网址 team for great efforts and keep up the same spirit.

- Regulatory Professional
US based, Global, Pharma Company

We have had a good impression of 澳洲幸运5开奖官网开奖正规网址 and feel more than comfortable telling partners that we are engaging with 澳洲幸运5开奖官网开奖正规网址 for our Regulatory needs. The project went very smoothly and we felt went along at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

-  Director, Regulatory Affairs
US based a leading precision medicine company

Wanted to share the good news that our BLA was accepted for filing by the FDA. We appreciate all of Freyr’s hard work that went into making this submission ACCEPTABLE!!

-  Head, Global Regulatory Affairs
US based biotechnology company

I am very satisfied with Freyr's credibility in my interactions. I received good advice that I felt was very above board. We had previously employed a consulting group that specialized in policy strategy and found that 澳洲幸运5开奖官网开奖正规网址 was able to accommodate those needs but also get to the practical needs of preparing and filing our application with the FDA. This was very important to me, and means that I will use Freyr's services in the future. Speed of service, responsiveness, attention to my needs, quality of product, and price are all very important and I felt they were very good in my work with Freyr.

We had a transition from one team to another during the process and it worked out well. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. In our interaction, I received good suggestions and advice and the 澳洲幸运5开奖官网开奖正规网址 team was able to adapt to my needs. Because we are always working under time constraints, this was very important. I felt we were able to get up and running quickly and respond to shifts quickly. Any time I had a question or needed support, I got rapid response and good answers to my queries. Rapid responses and ability to shift direction when needed was very good. I thought the support was very good and met with expectations. In addition, found the price reasonable given the work load.

-  Director, Regulatory Affairs
US based leading precision medicine company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and also how we operate, it is possible to realise our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team!

-  Operations Head
A Privately Held Pharmaceutical Research and Development Company

Congratulation!!! Thanks for great Support for successful ANDA filing. Especially for publishing team heartfully appreciate their last hours’ hard work.

-  Assistant Manager
A Privately Held Pharmaceutical Research and Development Company

overall it was great experience working with Freyr’s team and we were quite happy with the feedback the team has shared.

-  GM (General Manager)- Global Clinical Development
An India-based Pharmaceutical and Biotechnology company

Thanks for your extreme support during submission. It’s my pleasure to work with you. Without your hard work and dedication to work I guess we could unable to complete the task on time. Best of luck for your future projects and appreciate your efforts!!!!

-  Manager-Regulatory Affairs
US based, Global, Pharma Company

I wish to place on record my sincere appreciation for getting us to this point with the CTD update for our product. Your diligence, thorough input and timely delivery of all requests have been noted and is greatly appreciated.

-  Regulatory Manager
Global Top 5, Pharma & Consumer Healthcare Company

“Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified by the GRA Lead. This continuously demonstrates Freyr's commitment towards our company’s milestones, keeping the patient in mind.”

- Director
Global Regulatory Affairs - Operations
India based, Global top 5 Generic Pharma Company

“The Global Clinical Trial Application packages are now final (5 days prior to the agreed upon target dispatch of Sept 27) and have been dispatched to the CTLs and HUB (and out of HUB countries) to facilitate local health authorities and ethics committee submissions.
We would like to take the opportunity to thank 澳洲幸运5开奖官网开奖正规网址 for valuable contributions towards this CTA package under the stretched timelines of this RACE program.
We remain available for support with local HA submissions and queries to enable a successful FPFV.”

- Regulatory Lead – CTA (Clinical trials application)
Switzerland based, Global Pharmaceutical Company

“Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.”

- Senior Research Assistant
US based leading biopharmaceutical company

“We have accomplished one more major filing of PMA submission for devices on time. This submission US PMA (22nd April 2016) is one of our Milestones targeted for this year. Special note to mention that published output for this submission includes Paper Copy (-2500 pages) and eCOPY (150 document) which was independently handled by 澳洲幸运5开奖官网开奖正规网址 resource without any quality issues. Thank you for the outstanding work and quick turnaround to get it published on time which enabled project team to achieve the milestone. Keep up the good work going.”

- Global Franchise Head – Submissions
Switzerland based, Global Pharmaceutical Company

“This is fantastic news! Thank you 澳洲幸运5开奖官网开奖正规网址 for your extraordinary efforts to complete this major milestone on time.
Congratulations to the Core Team for your contributions to this achievement. The information that you generated through the development process and your assistance in pulling it together for this submission was amazing! It was very satisfying to read through the -2500-page document! ”

- Project Head, Vision Care Development
Leading global eye care company

Dear 澳洲幸运5开奖官网开奖正规网址 Team,
“You are truly awesome. I make that <60 mins response time is marvelous. Thankyou everyone! Indeed, that was a fabulous job for the team.”

- UK Regulatory Operations Lead
A Leading Pharmaceutical CDMO for APIs and finished dosage forms

“We are excited about completing the filing of BLA. We would like to send 澳洲幸运5开奖官网开奖正规网址 team, a gift of gratitude for the late hour’s work”

- Head, Global Regulatory Affairs
US based biotechnology company

“During the past several years, I’ve had the pleasure of working with 澳洲幸运5开奖官网开奖正规网址 Solutions in the publication, validation and electronic submission of regulatory documentation to the US FDA. The 澳洲幸运5开奖官网开奖正规网址 team had provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.”

- President
Leading regulatory and quality consulting company

Thank you very much. The illustration and detailed explanation on writing structure and presentation was well appreciated. Nice customer service!

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

Thanks for the support to Tech transfer most of the Launch artworks. Freyr’s commitment and follow up in meeting the timeline is appreciable. Nearly Six Launch products were tech transferred during your visit. Thanks once again and hope we receive your continued support.

-Sr. Coordinator
Canada based, global pharmaceutical company

Thank you, team, for your efforts in supporting several key launches over the last few months. Launches play a critical role in the growth of our business. Thank you to the entire team for your efforts and support in making our launches successful.

- Director
Canada based, global pharmaceutical company

Thank you ALL for the time and the tireless effort that you all have invested into getting these upto the stage they are in! 澳洲幸运5开奖官网开奖正规网址 team - this has been a challenging project, thank you all for your patience and understanding.

- Regulatory Affairs Associate
Canada based, global pharmaceutical company

Thanks, 澳洲幸运5开奖官网开奖正规网址 team for all your efforts with this artwork update! Really appreciated!

- Coordinator, Global Supply Program Management
Canada based, global pharmaceutical company

We really appreciate your help and support in the preparation of artwork. We also thank the graphic artists for their spectacular efforts.

- Associate, Regulatory Affairs Canada based, global pharmaceutical company

We are excited about completing the filing of BLA. We would like to send 澳洲幸运5开奖官网开奖正规网址 team, a gift of gratitude for the late hour’s work

- DGM Regulatory Affairs NPD
Canada based, global pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other points areas that you are thoroughly investigating, regarding the QA database etc.

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

I just wanted to say that this was nice customer service where you provided us with the visual of the label with 9 pt. (min font requirement) as well as the version with the 7 pt. That provided us the visual of what the label would look like with the reduced font. Best of customer service.

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

A huge ‘thank you’ to all those involved in the project for their extraordinary help in getting this artwork updated within such a short timeframe. This is greatly appreciated!

- Senior Regulatory Affairs Associate
Canada based, global pharmaceutical company

I would like to take this opportunity to appreciate 澳洲幸运5开奖官网开奖正规网址 in working collaboratively during this important launch. 澳洲幸运5开奖官网开奖正规网址 has been fantastic in supporting us all the way, keep it up.

- Deputy General Manager | Regulatory Affairs
Canada based, global pharmaceutical company

Thanks for your support to complete labeling deficiency response in one day. It is really a great job and appreciable….

- Associate, Regulatory Affairs
Canada based, global pharmaceutical company

You’ve all been involved in making this possible in various capacities and as you know, there’re many more 2D converted products to come soon. Let’s keep up the great work. On my opinion, we’re all part of something special here. I can assure you that we have many pharmacists, physicians, nurses and patients that need this 2D technology and who will benefit from it ASAP. Thank you all for your patience and support.

- Trade Dress Manager, Marketing
Canada based, global pharmaceutical company

I am very impressed on how quickly you were able to process this request. This is a great example of excellent customer service and striving to meet the upcoming process order.

- Graphics Project Leader
Canada based, global pharmaceutical company

Just wanted to thank everyone for their time and efforts to push this through to TT. Your time and assistance are sincerely appreciated.

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

Thank you very much for your tremendous efforts to follow up with CCRs and making sure none of them become overdue. Greatly appreciated!

- Supervisor, Change Management
Canada based, global pharmaceutical company

Thanks for turning this around so quickly! I kicked this off on Aug 23 (sent a proper GRF Aug 28) and in 3 weeks we now have new codes and a TT. That is AMAZING. Thank you for always pushing! Thank you for the fast turnaround with artwork creation and updates! I really appreciate this one!

- Coordinator, Marketing
Canada based, global pharmaceutical company

Many thanks for the approvals.
At the same time, I would not miss this chance to thank each one of you for taking that extra step to make this happen in a time of emergency!! Much Appreciated!

- Assistant Manager – Packaging Designing
Canada based, global pharmaceutical company

I am very impressed on how quickly you were able to process this request. This is a great example of excellent Customer service and striving to meet the upcoming process order for September 24.

- Graphics Project Leader
Canada based, global pharmaceutical company

Thank you so much for working on these and making them a priority. Your help is truly appreciated.

- Product Manager
Canada based, global pharmaceutical company

A huge thanks to 澳洲幸运5开奖官网开奖正规网址 for the excellent support in turning around 100 (approx..) lit references which were needed in a short period in support of an New Drug Application (NDA) submission.  Really appreciate Freyr’s dedication and hard work in making this possible.  This is a critical submission for us and therefore I wanted to take the time to let you know that the submission team recognize your contribution and are extremely grateful for your support not only for these but also for the hundreds of reports which you’ve republished to make submission-ready for this major submission.

- Submissions Manager
Switzerland based, Global Pharmaceutical Company

This is my team and I am more than thankful to all for making this initiative a great success. Without Freyr’s hard work we wouldn’t have achieved what we have

- Director Labeling
An American multinational biopharmaceutical company

It was such a pleasure to finally meet the Freyr’s team in person. I am so happy I was able to visit the 澳洲幸运5开奖官网开奖正规网址 office. I am very impressed with the wide scope of Freyr's expertise and I am excited about their innovative plans and the future of our companies' collaboration. I would like to extend my heartfelt gratitude and appreciation to everyone for the wonderful reception we received and as always for all the Freyr’s hard work.

- Manager Labeling
An American multinational biopharmaceutical company

On a quick note, let me thank 澳洲幸运5开奖官网开奖正规网址 for their resource’s professionalism and hard work. I wanted to share that one of our colleagues from the internal development team reached out to me to let me know that she had a great interaction with your resource and she appreciated how knowledgeable he is and how well he explained next steps/demonstrated understanding of what was needed, etc.

I appreciate your resource’s support.

- Labeling Cluster Head
Director, Global Labeling Management
WRO, Worldwide Safety & Regulatory
A leading Research-based Biopharmaceutical Company

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A leading Research-based Biopharmaceutical Company

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- Business Support Admin IV – GLM
WSR/Worldwide Regulatory Operations
A Leading Research-based Biopharmaceutical Company

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-Business Support Admin IV – GLM
WSR/Worldwide Regulatory Operations
A Leading Research-based Biopharmaceutical Company

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- Regulatory Affairs Officer
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- Labeling Cluster Head
Director, Global Labeling Management
WRO, Worldwide Safety & Regulatory
A leading Research-based Biopharmaceutical Company

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- Vice President, Regulatory Affairs
An India-based Multi-faceted Healthcare Organization

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A Specialty Pharmaceutical Company

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- Associate Director, Global Regulatory Affairs Operations
A Japan Based Leading Pharmaceutical Company

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- Associate Director, Global Regulatory Affairs
A Global Specialty Generic Pharmaceutical Company

On behalf of myself and my organization, I would like to take this opportunity to express our thanks to one of the Freyr’s resources, for his hard work. He worked extremely hard, diligent, and effective in helping us putting together the ANDA. He has exceeded our expectations.

We have noticed that his knowledge in the Pharma industry has significantly grown when compared to his previous visit to our organization. He illustrated stronger leadership personality and logical approach which coincided well with our team. My team and I enjoyed his time here, especially the day-to-day technical debates/discussions we had with him. He is extremely good at what he does and an open-minded individual. We had faced many challenges with this ANDA, but he kept his composure well and found a solution. It was truly a pleasure having him on site for the second time and we are very much appreciative of his hard work.

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A specialty pharmaceutical company

I am very pleased with Freyr’s performance. Even during high work pressure situation, the 澳洲幸运5开奖官网开奖正规网址 team did not hesitate to go an extra mile to complete the given submission on time. The team ensured smooth communication to complete the given tasks correctly as per the expectations of the company. 澳洲幸运5开奖官网开奖正规网址 also provided guidance for publishing activities to our in-house experts and helped solving our queries related to eSubmissions. The support of 澳洲幸运5开奖官网开奖正规网址 team is highly appreciated and I look forward to continue working with them in future, as well.

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A Japan Based R&D Driven Specialty Pharma Company

I would like to commend the 澳洲幸运5开奖官网开奖正规网址 team on their outstanding job to get 25 submissions out the door, on time. This shows that the team has put in extra efforts to tackle the additional task that was given to them on an ad hoc basis. I would like to appreciate the 澳洲幸运5开奖官网开奖正规网址 team for their great co-ordination and ability to handle large volumes of work effortlessly.”

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A Japan Based Leading Pharmaceutical Company

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Clinical & Regulatory Affairs Center,
A Korean Chemical Company

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A Global Bio-pharmaceutical Company

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- System Owner
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- Artwork Services Stakeholder
A Switzerland based Leading Pharmaceutical Company

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- Chief Quality & Regulatory Affairs Officer
A leading generic drug and pharmaceuticals company

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- Manager, Regulatory Affairs
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- CEO and Principal Consultant
A Japan-based Leading Pharmaceutical Consulting Company

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- VP, Regulatory Affairs
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Canada Based Global Pharmaceutical Company

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Canada Based Global Pharmaceutical Company

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Canada Based Global Pharmaceutical Company

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Canada Based Global Pharmaceutical Company

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US Based Leading Clinical-Stage Biotechnology Company

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Canada Based Leading Pharmaceuticals Company

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India based, Global Top Generic Pharma Company

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- President
A Healthcare Activation Leader in Providing Strategic Solution for The Rx/ OTC, Health Supplement, Processing Foods, Cosmetics and Medical Networking Business

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A Healthcare Activation Leader in Providing Strategic Solution for The Rx/ OTC, Health Supplement, Processing Foods, Cosmetics and Medical Networking Business

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– Associate Director Labeling Digital Enablement
One of the World’s Largest Pharmaceutical Companies

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– A Swiss-based Nutraceuticals Company

Thank you very much for a nice closure! It has been a pleasure working with you all. I want to take this opportunity to thank you for all your support with our newsletter's projects during the past 2.5 years, the excellent collaboration, and communication. The dedication and professionalism of your team were greatly appreciated. All the projects were delivered on time and were compliant with our quality standards.

The team followed attentively and patiently addressed all the changes in our IT systems and processes and acted as a true partner providing valuable comments to draw attention to some points or issues about the content. I enjoyed working with the team and hope we will have new opportunities to continue our collaboration in the future.

THANK YOU and Season's Greetings!!

– Regulatory Consulting Manager
A global leader in providing trusted insights and analytics

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A US-based Dietary Supplements Manufacturing Company

Documentation was very satisfactory. I thank 澳洲幸运5开奖官网开奖正规网址 for the participation throughout the NDIN process.”

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A Switzerland-based Nutritional Products Manufacturing Company

Freyr’s services are very good. We will move with other projects too.

– Pharmaceutics Lead – R&D
A Singapore-based Wellness & Fitness Company

The report is very clear and detailed with many valuable insights, which are of high quality. Very friendly and fast communication and support. Clear roles and responsibilities in the project, presented in a good way.”

– Regulatory Affairs Specialist
A Denmark-based Food Ingredient Manufacturing Company

Thank you very much for the report. It is very clear and helpful. I have received the information I was looking for and am now able to address our challenges!”

– Regulatory Affairs Specialist
A Denmark-based Food Ingredient Manufacturing Company

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– Quality Manager
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– Sr. Regulatory Submission Publishing Lead
UK based, Global Specialty Pharmaceutical Company

I just wanted to send you a quick note to let you know that Freyr’s resources have really stepped up this week. They are working on a submission that is taking an incredibly long time to prepare. They worked late last night and continue to plug away at it this morning. They have kept a positive attitude and have displayed true professionalism. I appreciate all that the publishers do for us, but I wanted to let you know how they have gone above and beyond this week.

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– Global CMC Technical Lead
A China-based Pharmaceutical Company

As always, thank you so much for your help with this submission! The efforts are very much appreciated!

– Sr. Regulatory Affairs Specialist
US-based, Multinational Pharmaceuticals CRO Company

“I’ll add my personal thanks and appreciation for all the good work and the extra efforts you have put in to support the NDA submissions. I really appreciate your expertise and accountability. Thank you for a job well done.

– CEO & President
US-based, Leading Innovator Pharmaceuticals Manufacturing Company

Thank you, Freyr, for your extraordinary efforts to support the mandatory NDA submissions. Submitting more than 20,000 files associated with the cardiac safety study required as a post-approval commitment was an unplanned activity. And the magnitude of the effort needed to receive so many files, process them to the appropriate format, and publish them for e-submission through the FDA gateway was a real surprise to all! We could not have accomplished this without your support and commitment after hours to get the work done correctly. You are a valuable and much-appreciated addition to our team.

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– Associate Director, Regulatory Operations
Japan-based Global Innovative Pharmaceutical Company

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India-based, Leading Multi-faceted Pharmaceutical Company

Dear 澳洲幸运5开奖官网开奖正规网址 team, I wanted to tell you how lucky/grateful/appreciative/thankful we are to have a support team like you to assist our last-minute submissions for new drug approval. This is a continuum of support from the team, but the recent one was another demonstration of excellence. Thank you!

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Ireland-based, Global Specialty Pharmaceutical Company

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- Senior Director, Regulatory Strategy & Operations
US-based, Leading Innovative Biopharmaceutical Company

Thank you all for the great support and expedited response to multiple FDA Information Requests (IRs).

- Chief Executive Officer
China-based, Leading Innovative Pharmaceutical Company

As a customer of 澳洲幸运5开奖官网开奖正规网址 Software Services Pvt. Ltd, we would like to express our appreciation for the high-quality and efficient work performed by your team in preparation and support of the software registration process in ANVISA. It was made possible to complete the project on schedule and achieve its goal as a result of the presence of highly qualified specialists, an established feedback system, and prompt resolution of any emerging issues.

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Russian Based Healthcare Software Development Company

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- Sr. Manager, Regulatory Affairs – Labeling and AdPromo
UK-based, Multinational Pharmaceutical and Biotechnology Company

I wanted to thank you and all the team who have worked on this project around the clock. You and your team exhibited good time management and customer service skills throughout the project by promptly responding to our queries and accommodating multiple iterations of the design and content. all of this has led the project to be delivered within such short deadlines.

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India-based, Multinational Pharmaceutical and Biotechnology Company

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Omniscient Neurotechnology

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- Director, Regulatory Affairs,
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As a customer of 澳洲幸运5开奖官网开奖正规网址 Software Services Pvt. Ltd, we would like to express our appreciation for the high-quality and efficient work performed by your team in preparation and support of the software registration process in ANVISA. It was made possible to complete the project on schedule and achieve its goal as a result of the presence of highly qualified specialists, an established feedback system, and prompt resolution of any emerging issues. We look forward to further fruitful and mutually beneficial Cooperation.

- General Director, Regulatory Affairs,
Russian Based Healthcare Software Development Company

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