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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.
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.
Some of the many ways regulatory data can be useful include:


  • Identify issues that a FDA district office frequently cites in inspection reports and help industry to cover the ground
  • Survey the competitive landscape to formulate regulatory strategies and gain business intelligence
  • Monitor approvals of new products, provide valuable regulatory input to sales and marketing
  • To be abreast of labeling changes to competitive products, to assess whether the changes might impact the market
  • Analyze adverse event reports
  • Assess review times for a category of product or reviewing division to detect trends and compare results
  • Keeping up with warning letters that might affect the market and to see shifts in policy implementation
  • Screening potential suppliers or distributors to guard against supply chain interruption
  • Monitor adverse event and recall data to detect problems in similar products to better inform the design process for new ones
  • Keeping current with the evolving requirements in guidance documents
  • Aiding in the selection of clinical investigators
  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:


  • Product approvals
  • Adverse event reports
  • Recalls
  • Guidance documents
  • Recent actions taken by government agencies

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.”

“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.


  • Decreased time for the approval of product
  • Decrease in the cost of the development of a product
  • Increased compliance
  • Identifies the opportunities for broader indications and identifies the roadmap for product approval
  • Identifies the hurdles like compliance hurdles and changes in requirements for specific indication
  • Predict agency review times and approval requirements
  • Answers specific development questions and maximizes target marks
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.
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.


  • Designed a product version for a global Top 5 Multinational Pharmaceutical and Consumer Healthcare Company
  • Completed an Africa related Pharmaceutical Regulatory and Market Intelligence project comprehensively covering deep insights across 7 Sub Saharan Regions
  • Freyr has a pipeline of 4-5 potential global business leads in the Regulatory Intelligence space


  • Provide strategic services in the CMC Regulatory Services space for an independent associated company
  • Freyr’s CMC Regulatory Affairs consultants will identify critical path activities and timelines to begin work on the project soon
  • The client has also engaged with Freyr for another EVMPD project, which is currently operational


  • Provide non-clinical documentation services using eCTD software for an Indian based integrated pharmaceutical company
  • Freyr undertook the task of compiling the non-clinical overview report (Module 2.4)
  • Worked in tandem with a medical practitioner, to review and successfully submit the report within the stringent timelines



  • Awarded regulatory services support contract by a Top 5 Global Pharmaceutical Company for its Drug Regulatory Affairs division for Middle East & African Countries (AMAC) and Latin America & Canada (LaCan) regions
  • In-scope activities include delivery of critical regulatory materials including regulatory components for product license renewals, registration samples & certificates
  • Liaised with global translation services core team and delivered operational support to regulatory activities related to new product planning for the regions


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


  • This section should contain a declaration letter in an official company letterhead stating that the product is free from alcohol


  • This section should contain a declaration letter in an official company letterhead stating that the product is free from any materials of pork/porcine source


  • The applicant shall include the price of the product in countries listed in the SFDA Guidance for Submission

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.



  • Successfully covered 12 Sub Saharan Regions in Africa
  • Multiple detailed submissions for diverse Health Authorities
CLIENT Global Top 5 Pharma and Consumer Health Company
GEOGRAPHY Africa/ Sub Saharan Africa Region
FUNCTION Regulatory Operations SOLUTION Publishing Services
  • Publishing Tool: docuBridge
  • Compatible Printer
  • Adobe Acrobat Pro


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.


  • Paper submission format demanded tab sheets, which were not aligned with the requirements of African countries
  • Printer compatibility did not permit the submissions for African region


Freyr offered the following regulatory services

  • Provided necessary requirements for changes to be made for existing tab sheets in alignment with regulations of African countries
  • Enabled printer compatibility with submission for African region
  • Swiftly adapted to different regulations across Africa
  • Worked to meet granularity of submission for 12 different countries
  • Provided the SSA publishing requirement to publishing tool vendor
  • Accurately aligned the tab sheets in DB within short span of time
  • Performed extensive gap analysis across the documents to maintain consistency
  • Supported dossier team in preparation of documents
  • Ensured compatible dossier publishing with the different printers used by client
  • Customized QC process ensured accurate submission publishing

Ensured scheduled and high quality submissions ahead of the stipulated timelines

Submission details for this project are as below:

Total no of Countries – 12
Total no of hours for each publishing – 38
Total no pages for each submission – 9688

Total no of Countries – 12
Total no of hours for each publishing – 38
Total no pages for each submission – 7785


  • A real-time overview of the program status and work was completed ahead of the stipulated timelines
  • Cost-effective solutions offered the client huge cost savings