Our team of experts provides regulatory and product development consulting services to our clients for biologic products regulated in both CBER and CDER. 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 BLA stages of product development.

Our expertise in biologics includes:

  • FDA Submissions and Interactions
  • Pharmacology/Toxicology
  • Clinical Trial Design and Evaluation
  • Immunogenicity Assessments
  • U.S. Agent Services
  • Expedited Regulatory Pathways
  • Orphan Drug Designations
  • Medical Countermeasure Applications
  • BARDA Funded Projects
  • eCTD publishing and lifecycle maintenance

Our biologics expertise spans across dermatology, oncology, GI and inborn errors, therapeutic vaccines, prophylactic vaccines, transplantation, and anti-infectives. Our team possesses the skills and knowledge to bring your product to the market quickly and efficiently.

We have specific expertise in the following:

  • Antibody-drug conjugates (ADCs)
  • Cell therapy
  • Gene therapy
  • Monoclonal antibodies (mAbs)
  • Vaccines

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