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Services

Partnering and Due Diligence

  • Strategic planning and assembly of data packages supporting partnering discussions
  • Due diligence review of existing safety programs to identify safety risks, mitigation plans, and data gaps
  • Fit-for-purpose development planning to set meaningful milestones and drive value

Gene Therapy Development

  • Global nonclinical strategy development
  • Disease model development & selection
  • Proof of Concept study design and endpoint selection
  • GLP toxicology and biodistribution studies
  • Sponsor oversight to meet quality standards of Regulatory Authorities
  • Study management and monitoring of GLP and non-GLP studies
  • Relationship management with contract laboratories and external collaborators
  • Accelerated regulatory pathways (e.g. Fast Track & Breakthrough)
  • Global regulatory submissions (e.g. IND, BLA)

Veterinary Drug Development

  • Global safety strategy development
  • Target animal safety
  • Human user safety
  • Study design, placement, monitoring, and reporting
  • Relationship management with contract laboratories and external collaborators
  • Global regulatory submissions (e.g. US, EU, Canada, Japan)
  • Due diligence and gap analysis

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