Facilitating compliant cross-border movement of investigational and commercial products. At Althian, we provide specialized regulatory guidance for the importation and exportation of pharmaceutical products, biologics, medical devices, and clinical trial materials across Mexico and Latin America. Our services are designed to help sponsors, CROs, and manufacturers navigate complex customs procedures, secure necessary permits, and ensure full compliance with health authority regulations at national borders.

Import Permit Management

• Preparation and submission of import permit applications for investigational drugs, medical devices, and biological samples.

• Coordination with COFEPRIS and customs authorities to ensure timely approvals and clearance.

• Advisory on product classification, tariff codes, and regulatory documentation required for entry.

Export Documentation & Compliance

• Preparation of export certificates, commercial invoices, and health authority declarations for outbound shipments.

• Support for international distribution of commercial products and clinical trial materials.

• Alignment with destination country requirements to prevent customs holds or rejections.

Border Health Authority Coordination

• Liaison with customs and health authorities to resolve queries, inspections, or documentation discrepancies.

• Monitoring of regulatory changes affecting import/export procedures in Mexico, Brazil, Colombia, and other LATAM markets.

• Strategic planning for temperature-sensitive or controlled substances requiring special handling.

Logistics & Supply Chain Advisory

• Integration of regulatory strategy with logistics providers to ensure compliant transport and storage.

• Support for labeling, packaging, and documentation required for customs clearance.

• Risk mitigation planning for time-sensitive clinical trial shipments and commercial launches.