Who we are

PharmaLex US, headquartered in the Boston, MA area and with affiliate offices in Chicago and Puerto Rico, offers a comprehensive portfolio of services to support you through the entire product lifecycle. Our US team of industry experts, over 225 strong, has successfully worked with every FDA review division and product formulation classification

  • PharmaLex US experts assist clients in navigating FDA requirements, act as FDA Agents to provide efficient agency communications, and work with sponsor teams to build collaborative relationships with FDA.
  • Our full-service portfolio includes Regulatory Affairs, Quality & Compliance, Pharmacovigilance, CMC, and Product Development Consulting. We provide significant value while offering flexibility to those in need of a condensed service solution for outsourcing, whether it is required to meet an immediate resourcing demand or to manage long-term projects.
  • We provide seamless integrated US, EU and worldwide regulatory strategies for global development projects.

Local Contact

  • Cassandra Adams
    Senior Director, Head of US Sales & Marketing PharmaLex US One Presidential Way Suite 109
    Woburn, MA 01801
    United States

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
  • 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
  • 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