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 One Presidential Way Suite 109
    Woburn, MA 01801
    United States
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Key members of our team

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 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.

Christina Rebel-Otterbach

Managing Director, PharmaLex US

20+ years accomplished in Finance and Business Leadership: focusing on Financial and Business Management, Organization, Global Expansion, Turnaround and Strategy with US and Europe-based companies operating globally. Christina has worked with global organizations, to drive operational excellence and scalability while increasing profitability and shareholder value.

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.

  • 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

  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited

  • 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

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

    Japan based medium sized company
    Manager

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