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Certifications

That provide framework for PX’ activities

An ambitious CDMO, PX’Therapeutics highlights quality as one of its assets. And offers proof of quality!

Here is what makes us at PX’Therapeutics proud of our service quality and ensures our very high customer satisfaction rates: 96% of satisfied or very satisfied customers.

 

Our GMP certification

Authorizations

 

  • GMP compliance certificate (last renewal in November 2017)
  • Biological substances and drugs manufacture for clinical use
    (GMP part I and part II GMP – quality control and certification for investigational medicinal products)

 

 

Inspections and audits

 

  • Regular inspection by the ANSM
  • PX’ received 100% qualifications during our customer audits (4 audits in 2016)

 

 

Best practices

 

  • Compliant with the ICH Guidelines, including Q2 (r1), and Q5
  • Member of SFSTP (French Society of Pharmaceutical Science and Technology), A3P, PDA (Parenteral Drug Association)