Ensure inspection readiness and regulatory compliance with expert GMP support. At Althian, we help pharmaceutical companies, CROs, and manufacturers prepare for Good Manufacturing Practice (GMP) inspections conducted by health authorities across Mexico and Latin America. Our specialized team provides strategic guidance, documentation review, and hands-on support to ensure your facilities, processes, and records meet the rigorous standards set by COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), and other regional agencies.

Pre-Inspection Readiness & Gap Analysis

• Comprehensive audits of manufacturing sites, documentation systems, and quality processes to identify gaps and non-conformities.

• Review of Standard Operating Procedures (SOPs), batch records, validation protocols, and quality control documentation.

• Mock inspections and simulation exercises to prepare teams for real-world regulatory evaluations.

Regulatory Inspection Coordination

• Strategic planning and coordination for inspections by COFEPRIS and other LATAM health authorities.

• On-site or remote support during inspections, including real-time guidance and documentation access.

• Liaison with regulatory inspectors to facilitate transparent, compliant communication.

Response to Findings & CAPA Development

• Analysis of inspection findings, deficiency letters, and observations.

• Drafting and submission of Corrective and Preventive Action (CAPA) plans aligned with regulatory expectations.

• Follow-up support to ensure timely implementation and closure of CAPAs.

Continuous Compliance & Training

• Ongoing advisory to maintain GMP compliance post-inspection.

• Staff training programs on GMP principles, documentation practices, and inspection protocols.

• Support for re-inspections, renewals, and international audits (e.g., FDA, EMA alignment).