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Quality

In the world of biologics manufacture, you depend on systems that ensure product quality and adherence to GMP regulations.  You also depend on a manufacturing partner with regulatory expertise and a proactive approach to mitigate quality risk.  Envigo’s cGMP manufacturing is designed to protect the integrity and quality of your product knowing that it is intended for human use. To ensure and demonstrate GMP compliance for our clients, Envigo operates a rigorous quality management system (QMS) including the following:

  • Personnel
  • Facilities
  • Equipment
  • Documentation
  • Defined procedures
  • Quality checking (QC & QA) 

Under the supervision of our GMP quality assurance managers, our team of expert QC analysts in the laboratory is dedicated to meeting both regulatory requirements and your highest quality expectations. Our quality control laboratories are compliant with EU and US FDA cGMP regulations, and you can maintain peace of mind knowing that Envigo has never received a major or critical finding (following 11 audits by these regulatory agencies). 

We also recognize that QMS is constantly evolving, and that is why we continue to assess, validate, and innovate to meet the changing dynamics of the regulatory environment. 

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