Preclinical GPS scientific services

Scientific Services

We manage the preclinical science and execution so that clients can focus on running their companies.

Preclinical GPS partners with clients to:

  • Develop and implement preclinical drug discovery/development plans from concept to market.
  • Accelerate timelines using customized preclinical and CMC plans.
  • Implement those plans using proprietary project management tools.
  • Outsource activities through qualified CROs and CMOs. This includes designing studies, generating requests for proposals, negotiating contracts, implementing studies, monitoring studies, reviewing data and preparing reports.
  • Author regulatory documents including IB, IND, CTD summaries, CTD tables, CTA, NDA, BLA, and MMA.
  • Build relationships with regulatory agencies while representing your company during pre-IND meetings and other interactions.
  • Conduct Gap Analysis for drug discovery/development programs.
  • Build or provide the team that will support the drug development program.
  • Manage budget and budget projections for R&D.
  • Estimate drug consumption for program and planned studies.
  • Prepare client companies for attracting partners and investors.

For new and existing biotech clients, Preclinical GPS also:

  • Supports fund raising through grants or investor meetings.
  • Provides Gap Analysis for preclinical and CMC programs.
  • Provides cost and timeline estimates for IND programs.
  • Identifies science-based go – no go decision points.
  • Conducts due diligence review of potential acquisitions.
  • Prepares clients for potential due diligence in acquisition processes.

For Venture Companies and investors, Preclinical GPS also:

  • Provides Gap Analysis for preclinical and CMC programs.
  • Conduct detailed analysis of preclinical programs.
  • Identifies and predicts potential preclinical issues.
  • Provides guidance on next steps and development needs to the next milestone.

Scientific services offered by Preclinical GPS include the following: