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 it 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, polysaccharide conjugate vaccines, whole Cell Bacterial vaccines, recombinant vaccines, and toxoid vaccines. Freyr also has extensive experience in supporting vaccine development programs, including COVID-19 Vaccine Regulatory support for developed countries, as well as the rest of the world and those with WHO pre-qualifications. At Freyr, we can also 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 the vaccine developers with the Registration of dossiers and WHO Product Summary Files (PSF) for WHO pre-qualifications.
Freyr Expertise has continuously evolved beyond end-to-end Regulatory for existing products to obtaining approval/authorization for new drugs including biologics, vaccines, rDNA derived products, monoclonal antibodies, blood products etc., and for newer therapies as they are discovered and are also being supported for emergency use or unmet medical needs with the benchmark Regulatory Agencies.
We believe that understanding Regulatory requirements in the right way is the key to success in today’s global market. It saves a company’s time, efforts, and investments.
Emergency Use Authorization Support
- Regulatory strategy for Emergency Use Authorization (EUA) request
- Regulatory evaluation of EUA requirements and data suitability assessment for EUA
- Managing gap analysis with the available documents/reports pertaining to specific markets
- HA interactions for EUA RTQ preparation and management
- Compilation of briefing summary/documents to Health Authorities
- Preparation and submission of Regulatory documents for EUA
- Expedited global MAH support
Post Authorization Phase:
Freyr ensures end-to-end Pharmacovigilance support including:
- ICSR case management
- Adverse Event of Special Interest (AESI), adverse events following evaluation (AEFI), PQC management, ICSR safety clinical database solutions, literature management and social media listening, aggregate reports, establishing safety signal management system and rapid response capability, preparation of Integrated Summary of Safety (ISS), risk management, PV audits including gap analysis, mock audits, training, and preparation of corrective and preventative actions.
Pre-submission Support and Guidance
- Early-stage Vaccines/Biologics Regulatory/New Chemical Entities services and consulting support
- Product evaluation for suitability under expedited programs/emergency use authorizations (e.g., fast track, breakthrough therapy, accelerated approval, priority review, PRIME etc.)
- Regulatory support during pre-submission meetings and various Agency interactions (US FDA CBER, EMA etc.)
- Regulatory strategy based on HA meeting outcome
Regulatory Services for USA, Canada & Europe Regions
- Regulatory gap analysis (review of product data), preparation of Regulatory mitigation plans and Regulatory strategies for BLA and MAA submissions
- Clinical and nonclinical medical writing services for IND, BLA, IMPD and MAA
- Vaccines/biologics CMC writing in eCTD format for clinical trial applications (INDs/IMPDs) and MAAs/Biologics License Applications (BLAs)
- Regulatory publishing and submissions in eCTD/NeeS format
- Strategic support including designing of Regulatory (GLP) Toxicology studies for IND/BLA/NDA submissions
- Vaccines/biologics CMC query responses/ information requests and end-to-end support for managing Complete Response Letters (CRL)
- Product life cycle management and need-based Regulatory support (e.g., biological product deviation reports submission)
- Change controls management & CMC variations/supplements/amendments
- US Agent services
Regulatory Services for ROW Market (Asia pacific African, Latin America, CIS regions & GCC countries (Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman.)
- Regulatory strategies, country-specific Regulatory gap assessment for biological products registration
- Compilation of product dossiers and query responses in the country-specific format
- Regulatory publishing and submissions in eCTD/NeeS format
- Change-control management and CMC variations/supplements/amendments
- Product lifecycle management and renewals
Regulatory Support for Biologics GMP Compliance (USA, Europe & ROW)
- Interpretation of the current GMP requirements/regulations for various biological products like, GMOs, recombinant proteins, cell-cultured based products, viral vaccines (live and inactivated) and supporting clients in designing GMP systems and procedures (compliance against 21 CFR Part 210, 211, Parts 600- 680, Eudralex Volume 4, etc.)
Regulatory Services for Vaccines Prequalification by the WHO
- Product gap assessment for 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 Product Launch in the Indian Market
The marketing authorization of a biological product in India follows a typical process and requires approval from various Regulatory entities like the Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC) and Central Drugs Standard Control Organization (CDSCO) and the State Licensing Authorities depending on the nature and type of the product.
Freyr provides end-to-end Regulatory support for the development, import permission/marketing authorization, registration of manufacturing facility (Registration Certificate) and Import License (IL Form-10) and lifecycle management of biological products manufactured within India as well as products manufactured and imported from abroad.