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
- Represent 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)