BIologics
Biological products such as vaccines, blood-derived products or human tissue derived products require special care during the manufacturing, testing and regulatory processes.
Biologics are regulated differently than traditional pharmaceuticals and are sometimes reviewed by a separate division within certain regulatory authorities. We can help you wade through this confusion and determine the correct regulatory process in your targeted markets.
Biologics are regulated differently than traditional pharmaceuticals and are sometimes reviewed by a separate division within certain regulatory authorities. We can help you wade through this confusion and determine the correct regulatory process in your targeted markets.
We offer the following biologic regulatory services:
- FDA Biologic License Application (BLA) submissions
- Regulatory document preparation and submission to authorities in the US, Europe, Asia & Latin America
- Country establishment licenses
- GLP & GMP audit assistance, including mock audits
- Pre-clinical trial meetings with regulators
- Clinical trial notification preparation and filing
- Facility registration & inspection
- Product development planning
- Institutional Review Board review and meetings