Regulatory

Writing non-clinical regulatory documents

We also author the following sections for IBs, INDs, NDA, CTA, and BLAs:

  • Introductions
  • Pharmacology
  • Safety pharmacology
  • Pharmacokinetic and ADME
  • Toxicology
  • Guidance to clinical investigators
  • Initial dose selection.

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.

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

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