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.

  • Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.

    US Biotech
    Senior QA Associate

  • PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.

    Top 10 Pharma Company
    President

  • In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.

    Thomas Dobmeyer, CEO PharmaLex
    CEO PharmaLex

  • 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

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