CMC

• Root cause investigation and failure analysis of processes or assays
• Analytical method development, transfer, qualification, and validation
• Process and assay evaluation and codification for formal documentation
• NGS data interpretation and off-target analysis
• Feedback on suitability of CQA (and ranges)
• Potency assay strategy development
• Stability testing support, including reports
• Assay development gap analysis
• Comparability strategy review, including study design and execution
• Advice on matrixed potency panels
• Remediation of analytical test failures
• Assay qualification and validation
• GLP assays

• Remediation of manufacturing/testing failures (especially at CDMOs, CROs)
• Facility design consultation (for scale-up, compliance, etc.)
• Quantitative capacity planning and throughput modeling
• Workforce development and technical training programs
• Project management support across tech transfer, scale-up, and vendor onboarding
• Interim functional leadership (e.g., QA lead, CMC director, operations head)
• Support for internal GMP facility planning
• CDMO selection and evaluation support

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• User Requirement Specification (URS) development
• Competitive landscape scan of existing devices
• Early-stage concept design and product strategy
• Search and selection of outsourced engineering partners
• Oversight of prototype development and testing
• Authoring of Design History Files (DHFs) and Device Master Files or Device Master Records (known as MAFs or DMRs, respectively)
• Generation of submission-ready technical documentation

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• Access to a proprietary CDMO database with selection filters by modality, scale, geography, and tech capability
• Proprietary quantitative CDMO selection methodology
• Design and management of the CDMO selection process
• Support for vendor audits, including on-site inspections and capability assessments
• Contract negotiation support (terms, deliverables, risk-sharing, etc.), including Quality Technical Agreement (QTA)
• Oversight of tech transfer activities (protocols, knowledge handoff)
• Management of ongoing manufacturing operations at selected sites
• Person-in-plant on-site support

• CMC and nonclinical gap analysis
• Product Development Plan (PDP) and roadmap creation
• Definition of Quality Target Product Profile (QTPP)
• Detailed Process and Analytical Development Plans
• Raw material strategy and critical supplier selection
• Milestone-based planning from FIH (First in Human, or F-I-H) through to BLA readiness
• Coordination of cross-functional activities

• Process Flow Diagram (PFD) authorship
• CMC gap analysis
• Portfolio prioritization
• High-level manufacturing strategy definition
• Capacity planning using custom quantitative models
• Supply chain strategy development, including redundancy, sourcing, and lead-time risk
• Cross-program CMC governance support
• Alignment of manufacturing timelines with clinical and regulatory strategy
• CMC roadmap
• Critical path identification