• Logistical, infrastructural, pricing, taxation and the regulatory landscape
• Members of Association of South East Asian Nations (ASEAN) and Latin American countries have harmonized their regulatory requirements
• Many countries have accepted ICH guidelines and CTD format however few regulatory authorities still have their own requirements and dossier formats
• Adopting new guidelines poses a challenge to the review process

• Language barrier impedes the approval process as guidelines are present in local language and dossiers have to be submitted to the local regulatory bodies in the required country’s local language
• Separate audits are carried out by the regulatory agencies of different markets
• Regulatory bodies in emerging markets face a shortage of experts/resources which delays the review process
• Expertise level required for review for Chemistry, Manufacturing and Controls (CMC), clinical and non-clinical of the dossiers also varies partly with different regulatory bodies

Technical Challenges & Possible Solutions

To encourage harmonization of regulations between agencies of both developed and emerging markets the following issues have to be addressed.

May be hampered owing to varying requirements of regulations for different countries. This can be minimised if various regulatory agencies initiate participation from the very beginning.

Global Stability Program

A demanding task due the fact that different countries fall into different temperature zones can be countered effectively if requirements of all markets that are targeted can be taken early on. Another suggested approach is to have batches on stability at both real time and accelerated conditions.

Global Clinical Trials

Ever since the introduction of ‘Kefauver-Harris’ amendments to FD &C act post thalidomide tragedy in the United States, drug development has been revolutionized compelling the manufacturers to demonstrate their drugs to be both safe and effective. The list of countries which want a clinical trial to be performed in their own populace has been on rise which made the industry to include patients from varying ethnicities and nationalities in their global clinical trial programs.

Using same packing inventory within that particular region, pharmaceutical firms can achieve harmonization. This in turn will help companies when regulatory agencies within that particular region achieve harmonization in the labeling needs. Pre-submission meetings unlike the developed markets, the absence of presubmission meetings or meetings for scientific advice will lead to issues after submissions are completed. The agencies and experts from industry should work to address technical concerns both at product developmental level and clinical study/bio-equivalence study level.

Freyr has been selected for a large regulatory submission project by a Global Top 20 Pharmaceutical company. The project will entail end-to-end services for regulatory submissions.

Artwork and Labeling Project for Top Global Manufacturer of Alternative Medical Products

Freyr has been awarded a global artwork and labeling project by a Top Global manufacturer of natural homeopathic remedies. This offshore project will see Freyr’s artwork and labeling CoE function involved in creation of artwork and labels for the client’s portfolio of products which will be marketed in multiple geographies.

Freyr has been engaged as a regulatory service provider of choice for a Top 5 multi-national pharmaceutical company for two consecutive regulatory service undertakings.Nine publishing associates will be deployed on-site at the client location to provide submissions publishing services including global submissions activity to FDA, EMA, LATAM and ROW in various formats (eCTD, NeeS, paper) and regulatory services for global eCTD submissions.

The Chief Medical Officer (CMO) of an US based biopharmaceutical drug development company visited Freyr’s office in the last quarter. The CMO met with Freyr management and sales team and conversed about emerging trends and service models in the regulatory space. The team also discussed about Freyr’s regulatory submission expertise and its proprietary tools EVMPD, rDMS, and Freyr Submit (eCTD). Freyr looks forward in supporting the bio-pharma company in their regulatory needs.

In the current quarter, Freyr was honored by the visit of a high profile Regulatory Affairs and Operations delegation from a Top-20, Global Pharma/Nutraceuticals Company at its office in Cranbury, NJ, USA. The delegation comprised of directors, managers and other staff from the customer’s Regulatory Affairs and Operations vertical met with Freyr’s core group of program managers, delivery managers, subject matter experts and project teams.The client thanked and recognized Freyr’s contribution towards the successful completion of a critical NDA submission. The project is significant as it is one of the largest submissions undertaken by the company, aided by Freyr. The client also talked about future opportunities and valued the partnership with Freyr, thus ensuring continued support from Freyr for their regulatory needs.

Freyr is entering a new growth phase by expanding its operations base and augmenting its vision to be a global leader in the Regulatory Solutions and Services domain. The new facility is slated to enhance and increase Freyr’s delivery capabilities in key areas aligned to the future growth plans.

Mr. Sudheer Sagar, VP Operations said, “Addition of the new facility was on the cards as part of our FY plan for 2014. Earlier in the year we had set into motion an

Freyr’s new facility will increases the Regulatory Workforce by over 20% and will serve as a strategic global delivery hub for Freyr’s Regulatory CoEs and R&D Services workforce that has been earmarked to globally deliver a wide range of services in the Regulatory Affairs, Regulatory Operations, Regulatory Intelligence and Regulatory Information Management areas.

The Accurate, Efficient and Faster UDI Compliance SolutionFreyr IDENTITY is the latest addition to Freyr’s growing Regulatory Software Solutions portfolio and is aimed at enabling medical device companies successfully navigate through the UDI compliance landscape.Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.Freyr IDENTITY ensures reliable regulatory compliance with GxP practice, 21 CFR Part 11 including additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to enable accurate, efficient and faster UDI compliance.

• In-built Version Control and advanced Validation as per FDA Algorithm
• Captures, configures and manages all the critical 62 fields of Device Identifier (DI) attributes and 6 fields of the Production Identifier (PI) attributes
• Auto XML Generation and GUDID Submissions compliant with HL7 & SPL
• Data configured to GS1, ICCBBA, HIBCC Issuing Agencies (IAs) Formats
• Processes validated data for label printing in accordance with AIDC & HRI
• Accurate Data Traceability and Tracking across multiple Lifecycles

Freyr IDENTITY takes up all the inherent challenges of medical device manufacturers and provides an effective and streamlined solution to meet the complex UDI Compliance requirements efficiently.

• Completes largest ever NDA submission (76 GB) in just ~2700 man hours for a global top 20 pharmaceutical company
• Significant improvement to the existing CSR process; turnaround time reduced from 60 days to just 5 days.

BUSINESS CASE

The client, a global top 20 pharmaceutical company, required round the clock support for its critical and strategic NDA submission which targets schizophrenia.  Freyr was also engaged to provide support for the client’s clinical study reports (CSR) projects.

CLIENT CHALLENGES

The client followed multiple highly complex processes for the NDA submission project which had multiple stakeholders spread across the geography.  The NDA submission (size ~76 GB) comprised of 1.5 million pages with 5,314 files, 937 folders, 300K bookmarks and 2.3 million hyperlinks.

Operational/quality/challenges with existing vendor had delayed delivery timelines impacting the client’s submission timelines. Existing vendor also had technology issues (viz. ad-hoc network downtimes, system failures and performance issues) with existing publishing and document management systems, Citrix and overall LAN network.  The client also faced issues with the existing vendor for delivery of high priority CSRs, who took six months to deliver each report, affecting stringent delivery dates.

FREYR SOLUTION

Freyr developed a strategic delivery model; established an account level PMO and an onsite program manager to manage individual projects; created a well-defined project plan; defined aggressive and objective performance parameters; deployed intelligent project budget tracking; created a communication campaign plan using innovative progress trackers and metrics to complete overview of real time project progress status. Freyr team used effective onsite-offshore model and was able to help the client deliver the submission ahead of the planned submission deadline.

CLIENT BENEFITS

Freyr helped the client submit critical NDA submission ahead of the planned timelines with zero defect quality. Overall Freyr team took ~6100 man hours over three different projects.

LARGEST NDA SUBMISSION

• Freyr team successfully delivered one of the largest ever NDA submission (76 GB) in just ~2700 man hours
• Shortest turnaround time in hyperlinking, bookmarking, publishing and QCing the submission files within the project

Clinical Study Report

• Significant improvement to the exiting CSR process; turnaround time reduced from 60 days to just 5 days.
• High productivity with lowest turnaround time