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Regulatory Consulting (Compliance & Affairs)

BioReliance regulatory consulting experts can satisfy questions raised by global regulatory agencies. 

 

Our regulatory consulting practice includes expertise in international regulatory compliance and regulatory affairs, and we assist clients in ensuring their testing programs meet current global regulatory expectations.

 

BioReliance offers global regulatory affairs support that includes:

  • Review of Regulatory Documents
  • Dossier Preparation and Submission
  • Training for International Regulatory Compliance
  • Biosafety, Manufacturing, and Regulatory Support

 

Our regulatory compliance and affairs consulting experts have worked with many of the top BioPharma companies. This added value service can prevent regulatory holds that delay the marketing of pharmaceutical products. BioReliance can also contact the regulatory agencies with or on behalf of our clients.

 

For Biologics Biosafety, Manufacturing and Regulatory Support, please contact info@bioreliance.com

 For Preclinical Toxicology and Regulatory Support, please contact tox@bioreliance.com 

 

What regulatory documentation submissions are available?

Correct compliance with regulatory rules set forth by global governing bodies requires an experienced consulting firm. BioReliance has extensive experience in the following regulatory documents, including but not limited to:

  •  New Drug Applications (NDA)
  • Biological License Applications
  • 21 CFR Part 11 Compliance
  • Pharmaceutical License Renewals
  • Common Technical Documents
  • And many more

 

Which international regulatory agencies are covered?

BioReliance understands that the potential marketplace for new biologics and therapeutics is worldwide. We take an international approach to regulatory affairs, specializing in regulatory consulting with the following agencies and regions:

  • United States, Food and Drug Administration (FDA)
  • The European Medicines Agency (EMA)
  • UK, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Australia, Therapeutic Goods Administration (TGA)
  • Various Regulatory Agencies in Asia and Southeast Asia

 

We will partner with you to help you determine the global regulatory strategy best suited to your biologics release project – contact us here.