PharmaLex US is headquartered in the Greater Boston area, with additional offices in Chicago, Virginia 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.
With a proven track record of assisting clients to navigate FDA requirements, act as FDA Agents to provide efficient agency communications, and work with sponsor teams to build collaborative relationships with the 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.