Our consultants have extensive experience evaluating and advising on strategic nonclinical pharmacology and toxicology issues including:

  • Nonclinical development plans
  • Excipient expert review and evaluation
  • Study design and interpretation
  • Critical review and gap analysis of IND, NDA/BLA submissions
  • Genotoxic impurities strategy
  • Planning, strategy, and interpretation of nonclinical enabling studies
  • Leverage of existing toxicology data for 505(b)(2) regulatory routes
  • Special Protocol Assessments for carcinogenicity
  • Preparation of eCTD Modules 2.4 and 2.6

Based on our extensive regulatory and contract research organization (CRO) experience, our consultants understand the complex details and timing of studies required by regulatory agencies. While managing your preclinical program, they integrate thorough scientific and regulatory requirements to ensure a robust nonclinical testing strategy. As the interface with your CRO, our consultants can:

  • Solicit bids and aide in laboratory selection
  • Develop protocols
  • Review data and reports
  • Manage nonclinical projects
  • Development and maintenance of timelines and budgets for preclinical programs
  • Preform GLP facility audits
  • Conduct data audits
  • Review and develop Standard Operating Procedures
  • Perform on-site study monitoring and prepare study monitoring reports
  • Lead and manage FDA interactions