Email Address

info@dunnregulatory.com

Telephone

703-577-8291

Clinical

Our consultants are experts in clinical development strategy and regulatory document preparation. Having guided clinical development and written numerous INDs and NDAs and BLAs, our clinical consultants can provide:

Clinical Strategy:

  • Develop key messaging for INDs, NDAs, BLAs and MAAs
  • Develop optimized clinical development plans

Medical Writing:

  • Develop and Write Protocols
  • Develop and Write Protocol Synopses
  • Write Clinical Study Reports (CSR)
    • Phase 1-3 including post-approval Phase 4 studies, if required
  • Write and Review Clinical CTD modules including;
    • Modules 2.5 and 2.7.1 through 2.7.6
    • Integrated Summary of Efficacy (ISE)
    • Integrated Summary of Safety (ISS)
    • Risk/Benefit Statements
  • Review Statistical Analysis Plans

Compliance:

  • GCP compliance expertise