Welcome to the latest issue of FREYRFOREWORD!
A monthly round-up of the latest happenings and updates from Freyr.
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NEW SERVICE LAUNCH: MAKING INROADS TO NEW STRATEGIC MARKETS
Freyr announces the global launch specialized regulatory services for new strategic markets -Africa & Sub Sahara Countries
REGULATORY INTELLIGENCE: DELIVERING A WEALTH OF INSIGHT
Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional.
CELEBRATING NEW CLIENT WINS
Our latest new client wins are a fantastic fit for our regulatory expertise and services, we’re absolutely delighted to be working on these projects for some of the Top Global Pharmaceutical Companies.
IN PERSPECTIVE: eCTD IMPLEMENTATION BY SFDA
The pharmaceutical industry is synonymous to being one of the most regulated industries in protection of health and well-being of the general public.
FREYR SUCCESS STORY
Learn how Freyr helped a Global Top 5 Pharma company to successfully complete detailed regulatory submissions in consonance with regulations of 12 diverse African countries within 168 person hours.
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| FREYR LAUNCHES SPECIALIZED REGULATORY SERVICES FOR NEW STRATEGIC MARKETS – AFRICA & SUB SAHARA COUNTRIES | ||||
| Freyr unveiled its suite of specialized regulatory services for new strategic markets that will cover Africa including the South Africa, Sub Saharan and North African regions like – South Africa, Ghana, Kenya, Nigeria, Angola, Uganda, Namibia, Zimbabwe, Zambia, Mauritius, Tanzania, Botswana and Malawi. | ||||
| Freyr’s specialized regulatory services suite is aimed at supporting Large and SMB Pharma/ Bio tech/ Consumer and Medical devices companies with end-to-end strategic regulatory services for their strategic regulatory needs across new emerging markets. Identifying a promising opportunity, Freyr has created a new regulatory market intelligence service that would help the pharmaceutical industry make crucial decisions and capitalize on unmet customer needs. | Freyr’s specialized regulatory services suite will offer – Medicine Registration, GMP Roadmap, CTD Conversion and Dossier Harmonization for new MAA. In addition, Freyr will provide strategic Pharmaceutical Regulatory and Market Intelligence Reports covering seven Sub Saharan African countries. The market intelligence reports provide the latest insights, analysis and forecasts within the Sub Saharan African Region at the country level, with a practical evaluation of new market opportunities and risks. | |||
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| Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision. Regulatory intelligence is an essential aspect to succeed in the regulatory landscape. Regulatory data must be harnessed and turned into actionable information as regulatory documents are readily available online and the right analysis, can deliver a wealth of insight. | ||||
| REGULATORY DATA: POTENTIAL USES Some of the many ways regulatory data can be useful include:
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Regulatory intelligence can be summarized “as actionable intelligence derived from assessment of the regulatory landscape.” Regulatory landscape can comprehend various types of publicly available information, such as:
Finding correlations between the massive amounts of data provided in hundreds of separate public databases that are not cross-referenced can prove strenuous but, the emerging field of regulatory intelligence has such tremendous capacity to inform the regulatory process that it should be an essential component of every regulatory professional’s toolbox. “RI can advance product lifecycle (value chain) in terms of procedural, technical, scientific and strategic input. Core roles include general information gathering and tracking legislation, followed by information dissemination and use. Procedural intelligence can include advising on marketing authorization applications (MAA) format and procedures, content and copy requirements in Europe and subsequent rest-of-the-world dossier preparation, plus compilation of internal working practice documents, templates and policies.” |
IMPACT OF REGULATORY INTELLIGENCE “RI focuses on the regulatory pathways associated with the drug development and approval process, often using historic decisions of regulatory agencies as a lens for potential future decisions.” RI contributes to every pharmaceutical company’s bottom line by helping the RA teams provide the highest quality submissions to agencies. If the FDA or European Medicines Agency (EMEA) delays approval of a regulatory submission because of a flaw in the application, the long-term sales of the new compound could be significantly affected, particularly if the company aims to be the first to- market in a specific drug class. BENEFITS OF REGULATORY INTELLIGENCE
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| CONCLUSION Regulatory intelligence has become a pivotal aspect of the regulatory affairs function. Regulatory personnel constantly seek out, analyze and communicate information about new guidance’s and requirements emerging from different markets. The goal of regulatory intelligence is to help companies stay updated on the regulatory environment to align the policies and product decisions with all relevant regulatory agencies. New regulations are also taken into consideration by the regulatory intelligence professionals, to help companies acclimatize themselves with the new requirements. Regulatory intelligence teams can keep local teams up-to-date on country specific regulations while global teams must align their product development with every regulatory environment in which they plan to market their products. Hence regulatory intelligence is important to all surveyed teams locally at the country level and at the global level. |
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| As an organization, we at Freyr, have always placed the highest value on our business associations and partnerships. It has been our guiding principle to identify newer opportunities and create exceptional engagement excellence for our clients that transform into long term relationships.As always, it is a great pleasure to announce the New Wins. | ||
| GLOBAL REG INTELLIGENCE SERVICES FOR $71bn TOP-5 CONSUMER HEALTH COMPANY
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STRATEGIC eCTD SERVICES FOR $10m INTEGRATED PHARMA COMPANY
GLOBAL REGULATORY SERVICES FOR $57bn TOP 5 GLOBAL PHARMA COMPANY
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| The pharmaceutical industry is synonymous to being one of the most regulated industries in protection of health and well-being of the general public. The regulatory policies of EU and US-FDA are deemed to be standard for the regulatory agencies worldwide.ICH brought together regulatory authorities and pharmaceutical industries of Europe, Japan and US for various aspects of drug registration.Similarly, countries from Asia Pacific and Gulf are in process of harmonization with mutual concern as The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC). The Gulf Cooperation Council (GCC) region is considered as “Emerging Market” for pharmaceutical export and bilateral trade. Ministry of Health of GCC states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE) are regulatory authorities for the regional Pharma sector. They also regulate prices of pharmaceutical products and bring about harmonization of varying prices and the regulatory process, the GCC implemented a centralized system, Gulf Central Committee for Drug Registration (GCC-DR) in May 1999, which currently runs parallel to the regulatory regimes in the region.
The Saudi Food and Drug Authority (SFDA) is the main drug regulatory body of Kingdom of Saudi Arabia (KSA) It is considered to be the most stringent and advanced body among GCC cooperation. To cope up with the ever changing regulation across the globe, SFDA has taken an initiative of adopting the efficient EMA directives and regulations. As a part of this initiative it has started accepting submission in form of eCTD from Jan 2013. |
Now that the guidelines has been efficiently drafted and success of the eCTD submissions till date SFDA has brought in new regulations stating that from Jan 2015 eCTD format is mandatory for filling any applications to SFDA. The SFDA eCTD Module1 is slightly different from EU Module1 that it contains additional information requesting the MAH to make declarations as listed below 1.7.5. ALCOHOL-CONTENT DECLARATION
1.7.6. PORK-CONTENT DECLARATION
1.8. PRICING
Freyr has been a strong player in providing eCTD services for various top global players in life sciences domain. In light of the new SFDA mandate, Freyr is realigning its service portfolio in line with SFDA regulations and is offering to expand its reach in the eCTD service landscape going forward in 2015. |
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| HIGHLIGHTS
BUSINESS CASE The client is a global top-5 consumer health company and has more than 250 companies located in 60 countries around the world with presence in several business segments comprised of franchises and therapeutic categories. The client had a challenging task of submitting two dossiers of a pharmaceutical product in alignment with different regulations of 12 African countries within seven days. Freyr was engaged to provide support for services which include compiling, configuring and validating the submissions in accordance with the regulations of 12 African countries and publishing solutions compatible with different printers used by the client. CLIENT CHALLENGES
FREYR SOLUTION Freyr offered the following regulatory services
Ensured scheduled and high quality submissions ahead of the stipulated timelines Submission details for this project are as below: HYDROCORTISONE (OINTMENT) HYDROCORTISONE (SUPPOSITORIES) CLIENT BENEFITS
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