What We Offer:

1

Regulatory consulting for pre-clinical and clinical developments of cell and gene therapy

  1. Regulatory strategy and implementation
  2. CMC section preclinical and clinical development
  3. Phase trial planning, trial design, statistical analysis and end point development
  4. Pre IND strategy and development
2

Operations consulting and management of cell therapy manufacturing and distribution

  1. Facility design, operational cGMP/ISO protocols and validation
  2. Facility staffing and training
  3. Facility operational optimization
  4. Manufacturing SOPs and quality
3

Commercialization strategy development of applied cell therapies

  1. Market sizing
  2. Sales channel development
  3. Pricing strategy
  4. Distribution strategy
4

Intellectual Property development in Cell and gene therapy

  1. Experimental design for IP development
  2. Freedom to operate analysis
  3. IP submission and follow up
5

International sales strategy of applied cell and gene therapies

  1. Order to cash process build out and implementation
  2. Accounting and financial consulting
  3. Trade compliance
6

Expertise in clinical and commercial supply chain solutions

  1. Cold chain technologies implementation
  2. Chain of custody and chain of identity tracking
  3. Packaging engineering and Labeling