United States - PharmaLex

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

Download Terms and Conditions

Key members of our team

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.

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.

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.

I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

Richard Blackwell
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!

Top 10 Pharma Company, China
Drug Safety Director
Worked with us and our contractors to help us achieve our tight targets, operate with our systems and procedures and are considered invaluable part of our team

US based large development group
VP Regulatory / Quality
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!

Astellas
Head of Ethics and Compliance, Astellas Pharma Europe