Overview

The control of infectious diseases is a major challenge for public health systems in both developed and developing countries. Vaccines play a significant role in the successful control of life-threatening, infectious diseases, that can adversely affect the population. Advanced biotechnological methods such as rDNA technology and cell culturing help in producing vaccines of assured quality, safety and efficacy.

Although the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the World Health Organisation (WHO) have already established a Regulatory framework for the regulation of vaccines, the other regions across the world are still at a nascent stage in establishing a Regulatory framework for vaccines at a national level in their own countries. As Regulatory compliance for each vaccine requires a special set of Regulatory skills and hands-on functional experience, organizations may find it challenging to navigate through the global Regulatory framework for Vaccines.

Freyr has a well-established infrastructure and the right expertise required to provide Regulatory services for all categories of vaccines: viral, poly saccharide conjugate vaccines, whole Cell Bacterial vaccines, recombinant vaccines, and toxoid vaccines. Freyr also has extensive experience in supporting Vaccine development programs for developed countries, as well as the rest of the world, and those with WHO pre-qualifications. At Freyr, we can also offer support in strategic planning right from the development stage, conduct Regulatory gap assessments and mitigation plans for identified Regulatory gaps, as well as preparation and submission of Vaccines Biological License Applications (BLAs)/ Marketing Authorization Applications (MAAs) and help with the Registration of dossiers and WHO Product Summary Files (PSF) for WHO pre-qualifications.

 

Freyr Expertise

Freyr has well established infrastructure and expertise to provide Regulatory support for marketing authorizations and life cycle management (LCM) of various biological products in the global market.

Freyr Regulatory experts have experience in all phases of a product life cycle (i.e. initial R&D stage, non-clinical studies, clinical studies, marketing authorization and post-approval LCM).

We believe that understanding Regulatory requirements in right way is the key to success in today’s global market. It saves a company’s time, efforts and investments.

Pre-submission Support and Guidance

  • Strategic consulting and Regulatory support for submission of Marketing Authorization Applications (MAA)
  • Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests
  • Product evaluation for suitability under Orphan Drug Designation, and Regulatory support for submission of Orphan Drug Designation requests

Regulatory Services for USA & Europe Regions

  • Regulatory gap analysis (review of product data) and preparation of Regulatory strategies to mitigate the identified Regulatory gaps.
  • CMC writing for clinical trial applications and Marketing Authorization Application (MAAs / BLAs)
  • CMC query responses
  • Product life cycle management
  • Change controls management & CMC variations
  • Biological Master File services for submission of information about process, methods and other advanced technologies (for example, gene sequencing techniques) that are proprietary in nature

Regulatory Services for ROW Market (Asian, African, Latin America & CIS regions)

  • Regulatory strategies, country specific Regulatory gap assessment for biological products registration
  • Compilation of product dossiers and query responses in country specific format
  • Change controls management & CMC variations
  • Product life cycle management

Regulatory Support for Biologics GMP Compliance (USA, Europe & ROW)

  • Interpretation of current GMP requirements/ regulations for various biological products (GMO, recombinant proteins, cell cultured based products, viral vaccines (live and inactivated) and supporting client in designing GMP systems and procedures

Regulatory Services for Vaccines Prequalification by the WHO

  • Product gap assessment for the WHO prequalification
  • Regulatory strategies development for Vaccines Prequalification
  • Compilation of Products Summary File (PSF) & query responses
  • Handling of variations
  • Prequalified Vaccines Annual Reports (PQVARs) submission

End-to-End Regulatory Services for Biological Products Launch in the Indian Market

Marketing authorization of a biological product in India follows a typical process and requires approval from various Regulatory entities like Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC) and Central Drugs Standard Control Organization (CDSCO) depending on the nature and type of the product. Freyr provides end to end Regulatory support for development, marketing authorization and life cycle management of biological products manufactured in-house (within India) and products imported from outside  India.