Expert in FDA/ICH/MHRA/TGA based GMP Audits, Volume 9A based Pharmacovigilance, Auditing BE-BA studies
1. To be your business Partner in India for conducting GXP compliance Audits on your API/Finished product suppliers. We can conduct customer oversight and check all the batch records of the material including traceability and recommend its shipment.
2. Pharmaceutical processing facility designer for APIs, Finished products and soft gels such that the package comes with full initial systems validation including material balance and flow, process flow diagrams and equipment specifications.
3. Computer systems installation and validation as per 21 CFR Part 11
4. Much more like cl...
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