CMC Technical Operations
Creative, cost and time efficient, scientifically rigorous solutions from chemistry through commercial product development.
Drug Substance
From procuring intermediates and regulatory starting material to route scouting and process development
- Management of contract manufacturing organizations and contract laboratories
- Experience and support with vendor selection activities
- Guidance with technical transfer of chemical processes
- Route selection and route evaluation
- Guidance on selection and justification of regulatory starting materials
- Process validation and continuous process verification experience
- Implementation of Quality by Design
- Help designing studies to characterize PARs and NORs
- Criticality assessment
- Performing or facilitation of technical risk assessments
- Guidance with potential mutagenic impurity control strategies
- Technical report writing, reviewing, and editing
Drug Product
From early tox formulations to clinical and commercial product development
- Lead optimization and preformulation
- Formulation risk assessment and optimization
- Implementation of Quality by Design (QbD)
- Formulation ruggedness and process robustness
- Process validation and Continuous Process Verification (CPV)
- Outsourcing strategies
- CRO/CMO selection and management
- Technical writing, research, training
Quality & Regulatory
Quality agreements, regulatory documentation, vendor audits, and inspection preparedness
- Quality Agreements
- Vendor audit service
- Quality risk assessment
- PAI readiness consulting
- Regulatory document writing, reviewing, and editing
- Experience with IND, IMPD, NDA, MAA and PAS filings
- Support with briefing booklets for health authority interactions
- FDA meeting prep
- Gap analysis for regulatory submissions
Supply Chain
Plan, source and deliver lifesaving therapies for every patient, on time, every time.
- Clinical demand modeling
- Clinical & Commercial supply planning
- Commercial Sales & Operations Planning (S&OP)
- Strategic capacity planning & management
- Materials and production planning and control
- Comparator and concomitant drug procurement and management
- Supplier/CMO identification, selection and relationship management
- Contracts negotiation and management
- Storage, distribution & logistics solutions and management
- Inventory strategy & management
- Packaging, labeling and serialization
