Our services
GxP Quality & Compliance Consultancy services
We provide tailored solutions to support your organization in setting / improving Research & Development, Clinical Development, Regulatory, CMC, Suppliers & QA Oversight processes & SOPs including management of CAPAs, Deviations, Serious Breach, Suppliers’s Quality Events, Qualification of CROs, CDMOs, Quality Agreement, IMP release
Creation / Upgrade of GxP Quality Management Systems / QA organization
Based on your GxP needs, we build GxP Quality Systems fit for purpose from R&D, pre-clinical, clinical phases 1 to 3 up to commercialization, with a pragmatic approach. Develop, support, coach & train your QA team, provide interim QA
Preparation & Support for GxP Audit/Inspection/Due Diligence
Which includes in addition :
1- Pre-Inspection training and Inspection set up
2- Inspection/Audit/Due Diligence preparation Story Boards
3- Review and audit of validation of electronic systems
4- Post-Inspection CAPAs & Follow-up
5- Backroom support during Mock Inspection/Inspection/Partner Audit
Gap Analysis/Process Mapping, SOPs evaluation, writing & reviewing
Which includes Process Mapping & assessment, creation of SOPs & Policies, drafting Process workflows & corresponding SOPs, in the field of R&D, Clinical Development, Regulatory, CMC, QA, Validation, IT, Data Protection & ESG
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