PharmaLex US

P.O. Box 441
Guilford, CT 06437

Phone: 203-415-7721

General Information:

With one of our US offices based in Guilford, CT, PharmaLex is one of the world’s largest providers of Regulatory Affairs, Development Consulting, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management.  Our team of experts will provide the necessary support to take you from early strategic planning and nonclinical requirements through to clinical development, the regulatory submission process and finally guide you to FDA approval.

We can help your company navigate FDA requirements, provide efficient FDA communications, and build constructive relationships with the FDA. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas, including small molecules, biologicals and all formulation types.  Whether you are a large or small pharmaceutical company, a biotech or medical device company, your requirements vary and we provide solutions across the spectrum.

Within PharmaLex, we strive to become your partner, and not just another vendor. We collaborate with you to advocate for your company, your ideas, and your products to the FDA and all global health agencies.