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.