Biologics
Biological products such as vaccines, blood-derived products or human tissue derived products require special care not only during the manufacturing and testing processes but also during the regulatory process. Biologics have their own set of regulations and are reviewed by a different regulatory in some instances.
RJR can help clear up this confusion by providing assistance in the following areas when dealing with Biological Products:
- Regulatory document preparation and submission for authorities in the US, Europe, Asia & Latin America
- Country establishment
- Facility registration & inspection
- Product development planning
- GLP & GMP audit assistance including mock audits
- Evaluation of standard operating procedures
- Pre-Clinical trial meetings with Regulators
- Clinical Trial Notification preparation and filing
- Assistance with selecting a Contract Research Organization (CRO)
- Institutional Review Board review and meetings
- New Drug Application submissions