RJR Consulting, Inc.
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Biologics

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

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

To veiw our case studies concerning our work with biologics please click here

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  • Home
  • About
  • Services
    • Pharmaceuticals
    • Medical Devices & IVDs
    • Biologics
    • Combination Products
    • Dietary Supplements
    • Cosmetics
  • Global Presence
  • Contact