Pharmaceuticals Audits Services PDF Print E-mail
Amreteck® offers following audits services: 

  • Develop and implement Audits preparation procedure for USFDA, MHRA, ANVISA(Brazil), Health Canada, EU, WHO or other regulatory organizations
  • Review Audits program for the plant and CMO
  • Develop Audits program for the plant and CMO if none exist
  • Work as a third party Auditor to approve suppliers/vendors
  • Perform PAI Inspection for the plants.
  • Perform Internal Audits to make ready for export countries regulators visits
  • Work for the companies during USFDA, MHRA, ANVISA (Brazil), Health Canada, EU, WHO or other regulatory inspections.  Develop and implement remediation plan for the Form483/observations given to the plants.
  • Develop quality agreements to approved suppliers and buyers.
  • Works as an independent certifying company for verifying quality of the products for both for the seller(s) and buyer(s)
  • Provide hands-on Audit Training to Company Personnel for Audit preparation.