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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