Discovery and Preclinical Research

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  • Project management and vendor oversight of GLP testing facilities and/or other vendors.

  • GLP qualification, routine, and for-cause audits of GLP animal testing facilities, specialty and bioanalytical testing laboratories, and final study reports.

  • Gap analysis of preclinical development plan and risk-analysis and mitigation planning.

  • Preclinical protocol and final report preparation and assessment and/or QA review and approval.

  • Preparation, assessment, and/or review of pharmacology/toxicology and pharmacokinetics (animal and human) sections of documents and regulatory submissions (i.e. INDs, NDAs, BLAs, DSURs, IBs, SPAs, Amendments to Modules 2 and 4, etc.).