GMP Compliance and facility registration

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  • Good Manufacturing Practices (GMP) auditing of manufacturing and testing facilities in accordance with FDA standards and expectations; assistance in preparation to GMP compliance and Pre-Approval Inspections (PAI) by FDA, Health Canada, and EU authorities
  • Assistance in responding to inspection observations, FDA Form 483, and Warning Letters, acting as liaison between FDA and the client
  • Review and revision of SOPs to ensure sound quality system and GMP compliance
  • Self-identification of manufacturing and testing facilities in line with GDUFA requirements
  • Electronic Establishment Registration of foreign manufacturing establishments with US FDA using SPL submissions via FDA Electronic Submission Gateway (ESG)