FDA Regulated Consulting Services | Oakton VA | Dunn Regulatory Associates, LLC

A Leader in Global Regulatory Consulting Services

Dunn Regulatory Associates, LLC’s expertise is in the development of Rx and OTC pharmaceuticals, biopharmaceuticals, and devices. Using an experience-based approach that integrates scientific expertise, business acumen, and regulatory strategy, we can streamline your product’s development from discovery to market. Our expert consultants are US and EU strategists, who have a proven track record of resolving even the most complex regulatory situations. We can:

Develop pragmatic approaches to regulatory challenges
Develop concise and thorough regulatory strategies
Lead regulatory meetings and meeting package preparation
Resolve complex pharmacology/toxicology, clinical or CMC regulatory issues
Write, manage, and review all modules of the common technical document (eCTD) from IND to BLA or NDA
Negotiate with the FDA and EMA