Good Manufacturing Practices Certification for Bulk Drug/Finished Dosage forms/Medical Devices/Cosmetics/Ayurvedic:
- Pre-consultation and information
- Plant Layout Suggestion & Plan approval subject to applicability
- Documentation (up to submission – Assistance or full support)
- Documents creation – all technical docs like SMF, DMF, VMP, SOP, URS, PVP, PVR, Stability protocols / reports and other requisite documents
- Review of existing documents
- Verifying source data
- Assistance in Compilation
- Final review before submission
- Facility visit for assistance before inspection by authority (Pre-audits & Gap Analysis)
- Query handling
- Final Approval for Mfg License/State GMP/WHO GMP/WC Certification/ISO 13485
Related Services from our Associate partners
- Services of: Concept layout planning, mechanical piping & utilities, process & utility equipment’s, Environmental management, HVAC etc.
- Services of: Tube source, fittings, sanitary clamps, valves, orbital welding, fabrication of filtration & pressure vessels, Water generation & Distribution, ETP/water purification.