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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