Regulatory & Drug Development

Having held positions within the FDA and the pharmaceutical industry, LTR professionals provide clients with an in-depth understanding of what it takes to bring a drug, biologic, or device from the concept stage to the market.

Complementing our internal expertise, we afford clients personal access to several hundred regulatory colleagues who collectively possess over 1500 cumulative years of past FDA and international regulatory experience. Their technical and policy expertise spans across all areas of regulation, including:

drugs
biologics
devices
diagnostics
generics
orphan drugs
over-the-counter products
food products

In short, our group represents the most knowledgeable, accessible group available regarding FDA requirements, procedures, regulations, and evolving policies.