About PharmaLex

PharmaLex US – FDA Regulatory Affairs Consulting  

Based in the United States, Benefiting from Global Reach

PharmaLex US LLC and its counterpart company PharmaLex Development Services LLC (PDS) provide expert guidance to companies seeking FDA Regulatory Affairs consulting assistance at all stages during the drug development process. Providing a custom service model, PharmaLex advisors provide a full spectrum of services from lead compound to post-marketing lifecycle management. We can help your company navigate FDA requirements, provide efficient FDA communications, and build constructive relationships with the FDA.

As the US affiliates to one of Europe’s most trusted service providers to the pharmaceutical industry, PharmaLex can prepare seamless integrated US, EU and worldwide regulatory strategies for global development projects. Delivering one-stop regulatory solutions can result in significant synergies, smooth communication, and faster development timelines for you.

Additionally, PharmaLex US Regulatory and PharmaLex Development Services can provide qualified and experienced onsite or remote based staff to fill department staffing shortages for short-term or long-term assignments.