Created in 2008 by Gรฉraud PAPON, Doctor of Pharmacy, ๐ฆ๐ ๐๐ข๐ก๐ฆ๐จ๐๐ง๐๐ก๐ is an independent, private French firm. We offer skills and Quality Supports to the pharmaceutical industry to support the compliance of activities with the requirements of health authorities and the expectations of internal or external customers. Our team consists of specialists in their fields, and adapt to the needs of the Principals in a relationship of #๐ฃ๐ฅ๐ข๐ซ๐๐ ๐๐ง๐ฌ, #๐๐๐๐๐๐ง๐ฌ and #๐ฃ๐ฅ๐ข๐๐๐ง๐ฌ.
๐ง๐ต๐ฒ ๐๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐ ๐ผ๐ณ๐ณ๐ฒ๐ฟ๐ฒ๐ฑ ๐ฎ๐ฟ๐ฒ :
- ๐ข๐ฃ๐๐ฅ๐๐ง๐๐ข๐ก๐๐ ๐ค๐จ๐๐๐๐ง๐ฌ ๐ฆ๐จ๐ฃ๐ฃ๐ข๐ฅ๐ง : on-site or remote full or part-time for CDMOs, operators, or MA holders : Supplier Quality Assurance, Product Quality Assurance, System Quality Assurance, or any other topic related to our skills for "classic" pharmaceutical forms or Biomedicines. We provide pragmatic, personalized and efficient support to contribute to the compliance of QMS 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).
- ๐๐จ๐๐๐ง๐ฆ : We carry out approximately 150 audits per year worldwide with the firm's salaried auditors, with a selected and exceptional use of partner auditors. The audits are mutualized if possible for mutually beneficial relationships for all. Audits can be private, and mutualized, a posteriori, if necessary.
- ๐๐ข๐ฅ๐ ๐๐ง๐๐ข๐ก : Intra company, Inter company, e-learning. The trainings are customized and adapted to the environment of our contractors.
๐๐ป๐ ๐พ๐๐ฒ๐๐๐ถ๐ผ๐ป๐? ๐ช๐ฒ ๐บ๐ฎ๐ ๐ต๐ฎ๐๐ฒ ๐๐ต๐ฒ ๐ฎ๐ป๐๐๐ฒ๐ฟ...