Biological products are complex medicinal products and include a wide range of subcategories such as, recombinant therapeutic proteins, monoclonal antibodies, cellular & gene therapy products, vaccines, blood & blood components etc. The Regulatory requirements for these products are vast and vary based on the type of product. Similarly, a separate set of Regulatory frameworks is being laid down for subsequent entry biologics, which are globally recognized as biosimilar products. Understanding the Regulatory framework and evaluating the requirements of each subcategory of a biological product in emerging markets (RoW countries) is challenging and demand complete knowledge of the product and country-specific Regulatory information.
When compared to major markets (e.g. US, EU, Japan, Australia), assessing the Regulatory requirements of the RoW market (Asia, Africa, Latin America, GCC & CIS regions) is more complicated due to the diverged Regulatory approach followed by different Health Authorities. Differences in the Regulatory requirements for each type of biological/biosimilar product and ever-evolving submission requirements of RoW Health Authorities make the registration and approval process more challenging. To overcome the hurdles and achieve successful submission in RoW markets, support from the proven Regulatory Affairs partners is of utmost need.
Freyr is a niche Regulatory service provider with significant experience in handling Novel Biologics, Biosimilars, Vaccines, Blood & Plasma products, Cellular & Gene therapy products across the RoW countries.
- Freyr has a good pool of industry and Ex-Agency experts with more than 25 years’ experience in the Biologics/Biosimilars Regulatory space
- Freyr teams have excellent technical and Scientific Competencies to handle Regulatory issues associated with different Recombinant Expression Systems (E.coli, Yeast, rCHO cells etc.) and different types of mammalian cell lines (Vero cells, MRC-5 cells, SPF CEF etc.)
- Successful track record in handling Combination products that contain biological product and device combination (PFS, Pen injector etc.)
- Regulatory Strategy for global expansion of biological products/biosimilars; this includes strategic planning for clinical trials in specific regions, stepwise approach for product registration in multiple countries, strategic approach in Regulatory Submissions and HA query responses
- Drug development strategy for Biosimilars; this includes, identification of Reference medicinal product, demonstration of analytical similarity, clinical data waivers, reducing the need for clinical data generation on local population etc.
- Regulatory Strategy/Regulatory insight reports for entry into new Row Countries
- Setting up the agency meetings and representing the sponsors to resolve scientific matters during the product registration
- Biological Product Registration in all Row markets (Asia, Africa, LATAM, GCC & CIS)
- Country-specific Regulatory Gap Assessment for registration of intended biological product/ biosimilar product
- Core dossier redaction/Dossier preparation Country-specific Formats, necessary support for translation of dossier into the local language and Regulatory Submissions management
- Submission Support for biological products CMC Variations/Amendments/Supplements to different Health Authorities
- Biological Product Lifecycle Management and Renewals