Services

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 regular drugs and are typically reviewed by a separate division at particular regulatory authorities.

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 licensing
  • 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
  • Biologic License Application (BLA) submissions

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614.304.0105