Documentation, due diligence and training
Documentation writing and review
Regulatory:
- Preparation and review of CMC section : IMPD, IND
- Participation to the preparation of Investigation Brochure and other documents
Contractual documents:
- Coordination of Master Service Agreement (MSA) review
- Preparation of quality agreement, proposal, pricing list, work order, scope of work
Technical document:
- non-GMP activities: protocol and report template preparation and review
- GMP activities: preparation of batch record, tech transfer protocol and report
CDMO selection:
- Preparation of Request For Proposal (RFP), User Requirement Specification (URS), score card
Due diligence evaluation
Licence-in:
- New project evaluation by reviewing CMC development strategy
- Document and report analysis
- Development and manufacturing budget evaluation
- Project developability
- Prerequisite report quality and availability
- Establishment of requested documents (if needed)
- Gap analysis, recommendation and report
Licence-out:
- e-dataroom preparation to license a product
- List of all CMC report to be uploaded in the e-dataroom based on regulatory dossier prerequisite
- Collect of documents on specific sharepoint
- Upload on e-dataroom
- Answer to client questions
Training
Biotech trainer in:
- Project management
- Pharmaceutical development of recombinant protein and Advanced Therapy Medicinal Products (ATMPs)
- Specific pharmaceutcial development steps
