We function as an extension of our clients’ R&D team by providing expertise and active management of scientific and regulatory issues, including:

  • Derisking Strategy
  • Candidate Selection and Lead Optimization
  • Exploratory Toxicology/Toxicokinetics program design
  • IND-enabling program design, monitoring, and management
  • Regulatory document preparation
  • Meetings with regulatory agencies
  • Due diligence
  • SBIR/STTR program support
  • Toxicology issue resolution
  • CRO selection and study monitoring
  • Licensing and partnering support

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