Empower your team with the knowledge to navigate Latin America’s regulatory landscape confidently and compliantly. At Althian, we offer specialized training programs and interactive workshops designed to equip sponsors, CROs, and pharmaceutical teams with practical, up-to-date knowledge of regulatory processes in Mexico and across Latin America. Our sessions are tailored to your organization’s needs—whether you’re preparing for a clinical trial submission, product registration, GMP inspection, or post-approval compliance.

Customized Training Sessions

• In-person or virtual workshops tailored to your product type, therapeutic area, and regulatory goals.

• Modules covering clinical trial applications (CTAs), product registration pathways, labeling compliance, pharmacovigilance obligations, and more.

• Hands-on exercises, case studies, and real-world scenarios to reinforce learning and application.

Regulatory Process Deep Dives

• Detailed walkthroughs of submission procedures, timelines, and documentation requirements for COFEPRIS and other LATAM authorities.

• Guidance on regulatory strategy development, dossier preparation (CTD/eCTD), and agency interactions.

• Updates on evolving regulations, regional harmonization efforts, and global alignment (FDA, EMA, WHO).

Compliance & Risk Management Training

• Best practices for maintaining regulatory compliance throughout the product lifecycle.

• Training on GMP inspection readiness, CAPA development, and post-marketing obligations.

• Advisory on internal audit preparation and documentation control.

Bilingual & Regionally Adapted Content

• Training materials available in Spanish and English, adapted to local terminology and cultural context.

• Support for multinational teams operating across Latin America.

• Integration of local case studies and regulatory precedents to enhance relevance and impact.