Quality and Regulatory Compliance

Global compliance without compromise.

Enabling a better quality of life for patients by delivering on our commitment to quality.

Quality and Regulatory Compliance

Avid Bioservices has over 16 years of successful regulatory inspection history and has been an approved manufacturer of products marketed in over 90 countries.  We aim to provide high-quality clinical and commercial product supply for our clients and in turn, to the patients.

We maintain the highest level of compliance by continuously improving our manufacturing and quality systems and processes.

 

Our quality team has extensive experience in ensuring a successful pre-approval inspection for your product and can offer support for your regulatory submission.

Our Capabilities:
  • Clinical & commercial manufacturing
  • Analytical methods development and qualification/validation
  • Full lot release capabilities
  • Stability testing
  • Drug product testing
  • Process validation support
Credentials & Compliances:
  • Six successful PAIs in 2005, 2012, 2014, 2015 and 2017 (2)
  • 2013, 2015, 2017 and 2018 FDA inspections resulted in zero 483s
  • Compliance with U.S. FDA, EMA, ANVISA, Canadian Health Authority, Turkey MoH and Australian Department of Health
  • Compliance with large pharma audits, including Roche, Takeda, and others

Our Quality Philosophy

Enabling a better quality of life for patients by delivering on our commitments to provide: high quality products, uncompromising compliance, and value-added services to our clients.

We maintain a focused vigilance on ensuring robust, integrated quality systems and compliance with worldwide regulatory agencies. We are dedicated to continually improving our processes and collaborating with our clients to enable success for their program.

The commitment to quality extends beyond just the Quality team.  Every Avid employee embraces and promotes this quality culture.  At the end of the day, it’s what the patients we manufacture these products for deserve.

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