GMP & GxP Audits for FDA, EMA, ANSM & ANVISA

Who it is for : Quality and regulatory teams at pharmaceutical, biotech, API, CDMO, cosmetics and chemical companies preparing for an inspection, qualifying a supplier or remediating findings.

What we audit : *GMP: stability, impurity profiles and validated analytical methods *Raw materials: traceability and control strategy *Excipients: documentation, change control and quality *Finished products and packaging: testing, release and compliance *Primary packaging items (ISO 15378) *Contract laboratories: files, equipment and training

Audit types : Supplier audits, re-audits, regulatory and pre-approval audits, gap analysis.

Proof : More than 1,000 audits a year, in France and internationally. 100% delivered on schedule. Recognised in ANSM, FDA and ANVISA inspections.

Standards : GMP, GxP, ICH, FDA, EMA, ANSM, ANVISA.