From discovery to First In Human, registration and commercialization, JEN Pharma Consulting supports small & medium biotechs and pharmaceutical companies to develop their Drug Substances and Drug Products
Development Strategy & Business Plans
- Drug Substance & Drug Product development plans
- Presentations to investors
- Formulation & analytical development
- Process development or transfer, scaling up & validation
Scientific & Technical Expertise
- TPP definition
- Technology selection
- Scientific presentations
- Plan of experiments
CMC Strategy & Quality Assurance
- CMC strategy & CMC writing
- Briefing Documents for Scientific Advices
- Meetings with Regulatory Agencies
- Gap analysis, risk assessment & mitigation plans
- Specifications & stability programs
Selection & Management of CDMOs
- Identification & selection of CDMO
- Requests for proposals
- Development & Supply Agreements
- Technical Quality Agreements
- Oversight & coordination of daily operations
- Review of documentation
