dTk Consulting provides a wide range of Regulatory Affairs support including the following:

Regulatory Strategy

  • Develop, evaluate, and/or prepare global regulatory product/submission strategies
  • Evaluate clinical, nonclinical, and quality programs for regulatory opportunities (e.g., expedited programs such as Breakthrough Therapy and Fast-Track designation, Priority review request, Orphan Drug designation, etc.)
  • Provide input on Special Protocol Assessment requests
  • Provide input on Pediatric Study Plans
  • Prepare clients for Health Authority meetings/interactions
  • Review quality design of experiments (e.g., alternative dosing, dissolution development)
  • Conduct regulatory Gap Analysis (e.g., due diligence for in-license opportunities)
  • Health Authority Interactions
    • ┬áRepresent client at Health Authority meetings/interactions (e.g., FDA meetings, EMA Scientific Advice)
    • Act as US regulatory agent for foreign clients

Regulatory Technical Writing

  • INDs (including informational amendments) and NDAs (including amendments, supplements, and 505(b)(2) applications)
  • Meeting packages (e.g., Pre-IND Meetings, End-of-Phase 2 Meetings, Pre-NDA Meetings, and Type A and Type C meetings, EMA Scientific Advice packages)
  • CTAs/IMPDs to support phase 1-3 clinical development programs in Europe
  • Breakthrough Therapy and Fast-Track designation requests
  • Orphan Drug designation requests
  • Priority review request
  • Pediatric Study Plans
  • Special Protocol Assessment requests (e.g., clinical and carcinogenicity protocols)
  • IND safety reports
  • IND Annual and/or IND/CTA Annual Development Safety Update Reports

Regulatory Project Management

  • Develop regulatory submission timelines
  • Manage preparation of submission content
  • Provide advice on regulatory operations (e.g., electronic publishing)