Who we are

Latin America is still lacking regulatory harmonization that extends across its 20 member countries. There are some regional and sub-regional initiatives to promote regulatory convergence, but work is still ongoing and the stage of maturity of the regulatory system varies significantly from country to country. The region presents a challenge for global drug companies, leading to longer approval timelines and a bigger strain on resources. In order to succeed in LATAM the pharma industry must balance its global expertise and systems while addressing country specific requirements and regulatory nuances.

PharmaLex in the LATAM region operates using a mixed/combined model, with own offices in the regions most important markets, coupled/paired with a long-established partnership with an expert local service provider RAFINT (Regulatory Affairs International S.A.C.)*.  Our partnership model ensures that PharmaLex can offer the full PharmaLex portfolio of products and services and using our central corporate operating system. This safeguards PharmaLex’s high-quality standards whilst at the same time enabling us to expand our products and services into new territories across the globe.

Covering countries including: Brazil, Mexico, Colombia, Peru, Argentina, Ecuador, Venezuela, Bolivia, Chile, Paraguay and Central American & Caribbean countries. PharmaLex LATAM has well-established local representatives with broad experience across the region. Their local expertise enables them to successfully navigate the regulatory landscape in each country, including significant experience in meeting with the local Health Authorities, such as DIGEMID (Peru) and COFEPRIS (Mexico).

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*RAFINT offers the core PharmaLex services specializing in regulatory affairs, including regulatory intelligence, maintenance, clinical trial applications and marketing authorization approvals. Supporting our existing LATAM operations, RAFINT seamlessly complements the PharmaLex portfolio offering our clients good value for money as well as confidence that their requirements will be met.

Local Contact

  • Fátima Monteiro
    Manager, Regulatory Affairs
RAFINT-logo

What our clients say about us

We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.

  • Highly competent, knowledgeable, absolutely reliable and dedicated to the projects

    Europe based medium-sized biotech development company
    Senior Director
  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications
  • We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.

    Med Device company, US
    Senior Regulatory Affairs Director
  • Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

    Small US Biopharmaceutical Company
    Sr Director Regulatory Affairs CMC