Registration of Pharmaceutical Products

Udelá Global provides end-to-end regulatory services for the registration of pharmaceutical products in Mexico and Latin America. Our team of experts supports companies in navigating complex local requirements, preparing and submitting dossiers, and ensuring full compliance with COFEPRIS regulations.

Our services include:

• Regulatory pathway assessment and strategic planning.

• Dossier preparation and submission in CTD/eCTD formats.

• Legal representation before health authorities.

• Coordination of translations, certifications, and technical documents.

• Ongoing communication with COFEPRIS to ensure timely approvals.

• Post-registration support, including renewals, variations, and pharmacovigilance.

With proven expertise in both national and international regulatory frameworks, Udelá acts as a trusted partner to accelerate market access while maintaining the highest standards of quality and compliance.