Integrated Regulatory & scientific consulting
services to the global
healthcare industry

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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
  • Strategically determine product placement
  • Serve as your US Agent
  • Leverage expedited regulatory pathways
  • Prepare Integrated Development Plans
  • Prepare Orphan Drug, Breakthrough Therapy, and Fast Track applications
  • Perform Due Diligence
  • Electronic Publishing Services (through the ESG)

WE ARE TRUSTED BY THE WORLD'S LEADING PHARMACEUTICAL AND BIOTECH COMPANIES

Our consultants are experienced US and EU regulatory strategists providing expert advice to companies across the globe