Biopharmaceutical Development Services | Charles River

regulatory compliance 

We understand your need to develop a biopharmaceutical product that meets the rigorous requirements of global regulatory bodies.  Charles River BPS has provided guidance to biotech companies on CMC Regulatory Compliance for biopharmaceuticals.  With more than 90 years of combined experience with the FDA, EMEA and MLHW agencies, BPS’ technical and quality assurance personnel can accelerate the development of your biological to meet regulatory compliance in the GMP/GLP testing and manufacturing environment.  

Regulatory Compliance Standards

  • Compendial Methods to meet Pharmacopeia Requirements
  • Q7A
  • Q5A
  • Q5C
  • Q5D
  • Q2 (R1)
  • 21 CFR 11, 210, 211, 58, 610, and 611
  • Eudralex
  • Aseptic processing

 

General Compliance Audit History

  • 13 FDA inspections since 1993
  • Routinely audited by domestic and international clients for GMP, GLP, and Q7A compliance
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For more information, contact us at:

1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

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Charles River Laboratories, Inc.