Non-Clinical Services

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A successful clinical program begins with a strong non-clinical foundation. GSAP helps organizations develop science-driven preclinical strategies that reduce development risk, support regulatory expectations, and generate the evidence needed to advance confidently into clinical development.

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Our services include:

  • Program Building & Gap Analysis
    Developing optimal preclinical development roadmaps and identifying structural safety and efficacy gaps early
  • CRO Selection, Audit & Oversight
    Evaluating and qualifying Contract Research Organizations (CROs) through technical and GLP compliance audits, and providing ongoing sponsor oversight to ensure data integrity and milestone adherence
  • Study Design & Oversight
    Designing, auditing, and managing crucial pharmacology, toxicology, biodistribution, and safety/tumorigenicity studies
  • Regulatory Writing
    Compiling, reviewing, and finalizing non-clinical reports and summary dossiers ready for regulatory submission