Latin America Regulatory Services
Leverage Mapi’s many years of experience working with individual health agencies across Latin America on projects at all stages
By partnering with the Mapi Latin American regulatory services team, you benefit from our many years of experience working face-to-face with individual health agencies across the region to navigate and expedite your company’s regulatory affairs plans, programs, and filing activities for successful market entry.
Our experts will clarify and negotiate the regulatory path for pharmaceuticals, biologics, NHPs, and devices in accordance with client-specific market regulations. Mapi meets your regulatory needs by engaging in a variety of project models, ranging niche expertise to dedicated onsite support.
Our team of Latin America regulatory professionals are based internationally, and offer diverse academic credentials, in-depth industry experience, and technical knowledge.
These specialists prepare and file submissions effectively, and use problem solving to achieve and maintain compliance at any stage of the product lifecycle.
Let Mapi be your integrated regulatory solution for entering the Latin American markets. We have the expertise to support your firm in the development of regulatory, clinical, and business strategies needed to expand or start up your business and operations in Latin America.
We work with a diverse range of national and international clients of all sizes to provide Latin American country-specific regulatory assessment, strategy design, product regulatory positioning, and guidance for client specific market entry. Clients benefit from scalable project models that are built to meet their unique needs and budgets.
We offer a broad range of regulatory services, including:
- Comprehensive submission preparation and publishing services / country specific
- Clinical trial applications (CTAs), site agreements and contract support
- New drug and biologic/Biosimilars submissions
- Nutraceuticals / Natural Health Products / Medical food submissions
- Cosmetics, new substance notifications, Cosmeceuticals
- Medical device filings (all classes)
- Preparation of Health Agency pre-meeting packages / country specific
- Regulatory CMC consulting services
- Full QA services, GMP Site Licensing support, product release; implementation of Quality Systems and Site Audits
- GMP, GCP and GLP training in Spanish and Portuguese
- Pharmacovigilance support / country specific (Spanish and Portuguese)
- Reimbursement support / National Formulary submission
- Literature searches / Competitive Market Intelligence / country / region
- Strategic Development Consulting / Regulatory Assessments – country / region specific
- Hosting / Representation agreements; licenses, permits, corporate-plant manufacturing registration support, Licensing-due diligence, Contract negotiations to deal closing
Mapi Strategic Regulatory Services
In addition to our Latin American regulatory services, Mapi provides comprehensive global commercialization capabilities including international regulatory affairs, pharmacovigilance, quality services, GMP auditing, health economics, market access, and late-phase research.
The Strategic Regulatory Group at Mapi has worked with companies of all sizes to manage regulatory projects around the world. Our team of experts is recognized for offering the deep collaboration and cooperation that only a truly global team can offer, working closely with clients, regulators, and the network of Mapi units to achieve success.