About

About UDELA Udelá is a regulatory consulting company. Udelá was created by a group of highly qualified professionals in the regulatory affairs field, with more than 15 years of experience, for medicines, medical devices, food, dietary supplements and cosmetics. Udelá is located in Mexico City, and has presence in Central and Latin America. Objectives - Provide technical and regulatory support, which accelerates the access of medicines, medical devices, food, dietary supplements and cosmetics on the market to improve the health of the population, through regulatory standard compliance and a build trust with regulatory agencies. - Bridge the knowledge gap of our clients in regulatory affairs to improve the communication with the regulatory agencies - Enhance processes of marketing authorization of medicines and medical devices (pre-marketing, registration and post marketing) to ease the access on the market and improve its maintenance - Active collaboration with our clients to generate better regulatory strategies to reduce timelines and optimize resources Services - Dossier compilation and evaluation o Medical Devices o New chemical entities/ New Molecules o Generics / Hybrids o Biotechnological products and Biosimilars o Vaccine o Biologics and blood derivative products - Design of regulatory strategies o Regulatory Due diligence o Feasibility studies for medicines and medical devices registration o Strategies for maintenance of existing and forthcoming products - Hosting & Testing services - Good manufacturing practices / License - Advertising - Translations - KOL feedback About UDELA Udelá is a regulatory consulting company. Udelá was created by a group of highly qualified professionals in the regulatory affairs field, with more than 15 years of experience, for medicines, medical devices, food, dietary supplements and cosmetics. Udelá is located in Mexico City, and has presence in Central and Latin America. Objectives - Provide technical and regulatory support, which accelerates the access of medicines, medical devices, food, dietary supplements and cosmetics on the market to improve the health of the population, through regulatory standard compliance and a build trust with regulatory agencies. - Bridge the knowledge gap of our clients in regulatory affairs to improve the communication with the regulatory agencies - Enhance processes of marketing authorization of medicines and medical devices (pre-marketing, registration and post marketing) to ease the access on the market and improve its maintenance - Active collaboration with our clients to generate better regulatory strategies to reduce timelines and optimize resources Services - Dossier compilation and evaluation o Medical Devices o New chemical entities/ New Molecules o Generics / Hybrids o Biotechnological products and Biosimilars o Vaccine o Biologics and blood derivative products - Design of regulatory strategies o Regulatory Due diligence o Feasibility studies for medicines and medical devices registration o Strategies for maintenance of existing and forthcoming products - Hosting & Testing services - Good manufacturing practices / License - Advertising - Translations - KOL feedback At Udelá, we empower healthcare companies—whether local or international, emerging or established—to enter and expand in the complex markets of Mexico and Latin America. With over 5 years of experience, we specialize in regulatory intelligence, market entry strategies, and end-to-end support for pharmaceutical products, biotechnology, medical devices, cosmetics, food supplements, and more. We understand that navigating the ever-evolving regulatory frameworks of Latin American countries can be overwhelming if not approached strategically. That’s where we come in. Our multidisciplinary team of consultants combines in-depth knowledge of regional regulatory environments with strategic execution capabilities. We act with precision, pragmatism, and agility to deliver timely and compliant market access solutions. Our key services include: Regulatory and strategic consulting for healthcare products Legal representation and in-country regulatory agent services Warehousing and distribution infrastructure compliant with national regulations With headquarters in Mexico City and operations in Colombia, Brazil, Chile, Perú, Ecuador, Uruguay, Paraguay, Bolivia, Argentina and Central America, we offer both local expertise and regional reach. Whether you're launching a generic, innovative, or biologic product—or seeking to expand your presence across LATAM—Udelá is your trusted partner in achieving regulatory clarity and commercial success. Where do you want to go next? Let’s go beyond, together.