Audit
- Internal audit and support for compliance implementation
- Preparation for inspections by regulatory authorities (ANSM, FDA, EMA)
- Approval of action plans
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Quality Control
- Physicochemical and microbiological analysis of raw materials and finished products
- Stability studies
- Optimization of analytical methods
- OOS / OOT / Data integrity
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Quality Systems and Data Integrity
- Implementation and maintenance of the QMS and monitoring of good manufacturing practices
- Data integrity
- Integration of HSE (Hygiene, Safety, Environment) requirements into quality processes
- Supplier management and evaluation
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Preparation for Regulatory Audits
- Preparation of marketing authorization (MA) dossiers and technical files
- Pharmacovigilance
- Market access
- Regulatory monitoring
They trust us in consulting
Did
you
know ?
We led Quality Assurance and technical engineering for an HVAC lot for a new vaccine production facility for a major CDMO.
Our teams manage your Quality Assurance on a daily basis, freeing up your talents for strategic projects.
We ensure operational Quality Assurance for a leading medical device company.
We have qualified multiple suppliers for a major player in Biotechnology.
We contributed to a €35M project aimed at doubling the production capacity of a biotechnology company.
