Company Profile

Company Overview

PharmaLex US Regulatory LLC provides expert guidance to companies seeking FDA Regulatory Affairs consulting assistance at all stages during the drug development process. Utilizing a custom service model, PharmaLex advisors provide a full spectrum of services from pre-IND to post-marketing lifecycle management. We can help your company navigate FDA requirements, provide efficient FDA communications, and build constructive relationships with the FDA.

Regulatory Affairs Services from Industry Veterans — Worldwide, Compliant, Flexible

PharmaLex offers unlimited support for drug development consulting, regulatory affairs and pharmacovigilance. Through our offices in the northeastern United States, we provide tailored services covering pharmaceutical product development, regulatory strategy and operations, CMC document writing and review, and life-cycle management. PharmaLex has extensive regulatory and scientific experience in most therapeutic areas, including small molecules and biologicals. PharmaLex can provide innovative outsourcing solutions with a flexible mix of on- and off-site support. We have a proven track record of success in outsourcing programs with more than 10,000 successfully completed projects for over 500 clients from around the globe of all sizes, including six of the top 10 global pharma companies.