Dunn Regulatory Associates’ regulatory and medical writers have extensive experience in researching and writing regulatory documents and position papers. To ensure consistently high-quality documents, we conduct quality control (QC) review of each document. Our efficient process not only delivers high-quality documents, but they are always produced within a timely manner. Most importantly, our operating procedures allow a collaboration between the client and DRA.

Our regulatory and scientific writing services include:

  • Regulatory Document Preparation
  • Investigational New Drug Applications (INDs) and Investigational Medicinal Product Dossiers (IMPDs)
  • New Drug Marketing Applications (NDA/BLA/MAA)
  • Abbreviated New Drug Applications (ANDA)
  • Special Protocol Assessments (SPAs)
  • Investigator Brochures (IBs)
  • IND/NDA/ANDA Amendments and MAA variations
  • Clinical Protocols
  • Annual Reports
  • Drug Master Files
  • Fast Track and Breakthrough Therapy designation requests
  • Orphan Drug Applications
  • Deficiency Letter Responses
  • OTC monographs
  • Technical and scientific review of regulatory applications
  • White paper literature reviews and summaries
  • Subject-specific literature searches
  • GLP and GCP compliant study reports
  • FDA meeting packages