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.

  • There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.

    Large Pharma, Global
    VP Regulatory Strategy
  • During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

    Large Pharma, Germany
    VP Regulatory Affairs
  • I have found the quality of both work and personnel to be unparalleled. Rina and the team have taken much time and care to understand our business and brand objectives. They have worked tirelessly to assist with a solutions-based focus and have maintained extremely high standards to support us. I cannot imagine another supplier providing this level of service.

    AstraZeneca
    National Professional Relations Manager, AstraZeneca
  • Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!

    Astellas
    Head of Ethics and Compliance, Astellas Pharma Europe