Who we are

Today’s ever-changing market requires expertise and innovative solutions to overcome the challenges of tomorrow. PharmaLex is a global company with experts operating all over the globe, including Brazil. We have established and maintained a global network of local representatives, covering all of the services offered by PharmaLex across Latin America (LATAM), including Brazil, since 2002.

  • Well-established local representatives with broad experience across Brazil and the LATAM region.
  • Strong experience with meetings with the local Health Authorities.
  • We cover all of the services offered by PharmaLex across Brazil, including end-to-end services from the pre-submission regulatory strategy (including the validation plan and its execution) to the marketing authorization and the life cycle management activities. Our resources are highly experienced with facilities start-up, product or technology transfer projects as well as with sustaining operations.

For customers looking for support in Brazil, PharmaLex offers the option to have a single point of contact, who will manage and oversee entire functions as well as manage the liaison between our customers and our local experts on site.

Local Contact

  • Fátima Monteiro
    Manager, Regulatory Affairs
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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.

  • What was especially important to me was their ability to get a team, with the right experience, together so quickly.

    Mid-size Biotech
    Head of Outsourcing

  • We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.

    Small Medium Sized Company, UK
    Head of Regulatory Affairs

  • 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

  • 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

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