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
  • 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

  1. Services of: Concept layout planning, mechanical piping & utilities, process & utility equipment’s, Environmental management, HVAC etc.
  2. Services of: Tube source, fittings, sanitary clamps, valves, orbital welding, fabrication of filtration & pressure vessels, Water generation & Distribution, ETP/water purification.

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