Who we are

PharmaLex US is headquartered in the Greater Boston area, with additional offices in Chicago and Puerto Rico as well as  remote staff located throughout North America. We offer a comprehensive portfolio of Regulatory Compliance services to support pharmaceutical, biopharmaceutical, and medical device organizations through the entire product lifecycle. PharmaLex accelerates your development timeline by leveraging our US team of 225+ experts, that provide effective right-sized service solutions with significant value and maximum flexibility.

  • Our full-service portfolio includes Regulatory Affairs, Quality Management & Compliance, Pharmacovigilance, and Integrated product Development Consulting.
  • Proven track record of assisting clients in navigate FDA requirements, act as FDA Agents to provide efficient agency communications, and work with sponsor teams to build collaborative relationships with FDA; from pre-IND meetings to post-market remediation follow-up.
  • We are equipped to partner with your organization from discovery through commercialization to ensure compliance and efficiency along the way.
  • We provide seamless integrated US, EU and worldwide regulatory strategies for global development projects.

Our focus on matching phase appropriate solutions to your organization’s specific needs differentiates PharmaLex as a leader and as a go-to company for a broad spectrum of complex strategic and “day to day” tactical consulting services.

Local Contact

  • Cassandra Adams
    Senior Director, Head of US Sales & Marketing PharmaLex US 1700 District Avenue
    Suite 100
    Burlington, MA 01803
    United States
    +1 (617) 831-9179

Key members of our team

Tom Fritz
Tom Fritz

Partner, Principal Consultant, Integrated Product Development, PharmaLex US

Tom is a recognized integrated drug development expert for pharmaceutical and biological products. He has spent over 30 years working with companies as both an executive and as a consultant to plan, organize, and manage drug development programs to fruition and build company and product value.

Limaris-Alvarado-Mercado
Limaris Alverado

Partner, Principal Consultant, QMC & MDS PharmaLex US

Limaris has over 20 years of experience working in various tactical and strategic roles within the biopharmaceutical industry as both an employee and a consultant. Her experience includes the management of more than 10 product transfers/launches (from development to commercial and from manufacturing “sister site” into commercial site) achieving successful consecutive prior-approval and routine inspections.

Susan Maue
Susan Maue

Managing Director, PharmaLex US Corporation

As an Industrial Engineer, Health Outcomes Researcher, and business executive with 20+ years of experience in the pharmaceutical industry, Susan has focused on delivering consulting services that help patients gain access to life-changing medications and improve the delivery of safe, effective clinical care, while building systems that ensure the best customer experience.

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
  • 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
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager
  • 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