We work on site or remotely, full time or part time, for CDMOs, marketing authorization holders and suppliers of pharmaceutical industry, on the following subjetcs : Supplier Quality Assurance, Product Quality Assurance, System Quality Assurance, Quality Control, Production of all galenic forms (including the new Annex 1), or on requests on other subjects in line with our skills and the expectations of the authorities.
We provide pragmatic, personalized and effective support to help bring QMS into line with the requirements of health authorities, internal and external customers in Data Integrity, Risk Assessment, Qualification / Validation Policy, Pharmacovigilance, Purchasing and other areas of expertise through internal audits, or preparation for inspections (MOCK INSPECTION).

We carry out around 100 to 150 audits a year in France (50%), the rest in Europe (35%) and elsewhere (15%), using the firm’s salaried auditors and, on an exceptional basis, selected partner auditors. Audits are shared whenever possible to ensure mutually beneficial relationships. Audits can be private, shared or a posteriori, depending on your request

We train pharmaceutical professionals to meet the requirements of the Authorities (Management of Pharmaceutical Transport / Qualification – Validation of equipment in pharmaceutical environments…) in intra-company, inter-company and e-learning sessions. Our training courses are customized and tailored to the environment of our contract givers.

We complement your Quality Management, Project Management and Supply Chain Management teams with specialized personnel selected according to your human and technical requirements.