DP Clinical has successfully supported global sponsors with their regulatory IND/IDE/NDA/BLA filings for drugs, biologics, and devices, as well as global health authority interactions throughout the development cycle. DP Clinical draws on its valuable experience in planning and managing essential document and Institutional Review Board (IRB) submissions in order to move projects forward. We understand the importance of meeting tight timelines and rely on our regulatory and therapeutic experience as well as our site and IRB/Ethics Committee relationships to ensure studies are started as quickly as possible and maintain regulatory compliance through completion.

DP Clinical’s regulatory affairs services include:

IND/NDA Development/Submission Services

  • Global regulatory strategy for clinical development of products
  • Regulatory CMC consulting
  • FDA meetings/communications (pre-IND, EOP2, Pre-NDA)
  • Regulatory Designations (Fast Track, Orphan Drug, etc.)
  • INDs (IDEs)/NDAs (BLAs,510Ks)
  • sNDAs, ANDAs
  • Regulatory submissions/interactions with other health authorities through partnerships

IND/NDA Life-Cycle Management (Maintenance)

  • Amendments to IND
  • Annual reports to IND/NDAs
  • Ongoing interactions with FDA/other health authorities through partnerships

Study Regulatory Support

  • Recruitment and subject information materials preparation
  • Informed Consent Form development
  • Vendor qualification
  • ClinicalTrials.gov set up and maintenance
  • Advertising and promotional materials preparation
  • Maintenance of documentation and records review
  • Obtain certified translations in various languages