What We Offer:
1
Regulatory consulting for pre-clinical and clinical developments of cell and gene therapy
- Regulatory strategy and implementation
- CMC section preclinical and clinical development
- Phase trial planning, trial design, statistical analysis and end point development
- Pre IND strategy and development
2
Operations consulting and management of cell therapy manufacturing and distribution
- Facility design, operational cGMP/ISO protocols and validation
- Facility staffing and training
- Facility operational optimization
- Manufacturing SOPs and quality
3
Commercialization strategy development of applied cell therapies
- Market sizing
- Sales channel development
- Pricing strategy
- Distribution strategy
4
Intellectual Property development in Cell and gene therapy
- Experimental design for IP development
- Freedom to operate analysis
- IP submission and follow up
5
International sales strategy of applied cell and gene therapies
- Order to cash process build out and implementation
- Accounting and financial consulting
- Trade compliance
6
Expertise in clinical and commercial supply chain solutions
- Cold chain technologies implementation
- Chain of custody and chain of identity tracking
- Packaging engineering and Labeling