Our team of experts provide regulatory [505(b)(1) and 505(b)(2)] and product development consulting services to our clients. Dunn Regulatory Associates, LLC has a track record of efficient, success-driven regulatory strategy and implementation. Our consultants bring decades of experience from pre-IND through NDA stages of pharmaceutical product development.

Our expertise in pharmaceuticals includes:

  • FDA Submissions and Interactions
  • Pharmacology/Toxicology
  • Product Manufacturing
  • Clinical Trial Design and Evaluation
  • U.S. Agent Services
  • Expedited Regulatory Pathways
  • Orphan Drug Designations
  • eCTD Publishing and Lifecycle Maintenance

Our small molecule expertise spans across all Divisions of CDER including dermatology, oncology, pulmonary, GI and inborn errors, neurology, psychiatry, metabolism and endocrinology, ophthalmology, dental, anti-infectives (including anti-virals and antibiotics). Our team possesses the skills and knowledge to bring your product to the market quickly and efficiently.

We have specific expertise in the following:

  • Small molecules
  • Combination products
  • Dietary supplement ingredients
  • Peptides and proteins

Our goal is to work collaboratively with Pharma to bring novel, life changing products to patients quickly and efficiently. Our regulatory expertise allows us to develop innovative strategies in conjunction with robust science to help you achieve your goals and improve the lives of patients.