Regulatory

Preclinical GPS represents you and your nonclinical program during interactions with the FDA, Health Canada, and EMA, as well as other regional regulatory agencies.

Writing non-clinical regulatory documents

We author the nonclinical sections for IBs, INDs, NDAs, CTAs, and BLAs as well as preINDs:

  • CTD 2.4 Nonclinical Overview
  • CTD 2.6.1 Introduction
  • CTD 2.6.2 Pharmacology Written Summary
  • CTD 2.6.3 Pharmacology Tabulated Summary
  • CTD 2.6.4 Pharmacokinetics Written Summary
  • CTD 2.6.5 Pharmacokinetics Tabulated Summary
  • CTD 2.6.6 Toxicology Written Summary
  • CTD 2.6.7 Toxicology Tabulated Summary
  • Guidance to clinical investigators
  • Initial dose selection
  • PreIND Briefing Book

Regulatory interactions

Preclinical GPS also represents you and your program during interactions with the FDA, Health Canada, and EMA, as well as other regional regulatory agencies. We help develop positive relationships with FDA during pre-IND meetings, at IND submission and during End of Phase 2 meetings. We ensure that your customized preclinical program will satisfy the requirements of these agencies.

Compliance

We ensure appropriate compliance with GLPs, OECD guidance, and ICH guidance, as well as regulatory requirements for global regions.