Our four fine chemicals facilities operate according to the highest quality standards, such as European GMP (Part II), ICH Q7A, and/or current GMP,… to ensure that regulatory and customers’ requirements are fulfilled.
All facilities are regularly inspected by governmental agencies such as the US-FDA or EDQM, and/or local health authorities (e.g. French Medicine Agency, AFSSaPS), as well as by our customers.
Our site-specific Quality Assurance system is continuously improved upon internal and external auditing.
OVERVIEW OF QUALITY SYSTEMS
REGULATORY AFFAIRS
To support your IND, (A)NDA and MA applications, our regulatory support includes :
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Process Validation
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Method Validation, based on ICH guideline Q2
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Stability Studies , based on ICH guideline Q1
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Risk Analysis (on-going), based on ICH guideline Q8
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Filing of E-DMF, US-DMF, CEP, CMC sections, annual reports,…