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 typically reviewed by a separate division by some regulatory authorities. We can help you wade through this confusion and walk you through the regulatory process
Biologics are regulated differently than traditional pharmaceuticals and are typically reviewed by a separate division by some regulatory authorities. We can help you wade through this confusion and walk you through the regulatory process
We offer the following services in the area of Biologics
- Biologic License Application (BLA) submissions
- Regulatory document preparation and submission to authorities in the US, Europe, Asia & Latin America
- Country establishment license
- 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