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o Make versus Buy Decision Trees
o Integrated Timelines
o CMO Selection and Oversight
o Management of Process Development (Cell Line, Upstream Process, Downstream Process, Analytical Methods, Formulation, etc.)
o Process and Product Characterization
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o Target Identification and Validation
o Lead Identification and Validation
o Target Product Profile Creation and Assessment
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o Design and Oversight of IND Enabling Non-Clinical Studies
o Management of Bioanalytical Methods Development, Qualification, and Validation
o CDMO Selection and Study Oversight
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o Regulatory Strategy
o Preparation of Briefing Documents for Pre-IND or Scientific Advice
o Preparation of Submissions (Pre-IND, IND, BLA, etc…)
o Health Authority Interactions (FDA/EMA/NMPA/National Health Authorities)
o Accelerated Regulatory Pathways (Fast-Track, Breakthrough Therapy Designation, Orphan Drug Designation)
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o Design and Implement Quality Systems
o Oversight Quality Control and Quality Assurance
o Risk Management
o Gap Assessment
o On-Site and Virtual Auditing of CMO Partners
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o Timeline Construction and Management
o Budget Management
o Regularly Scheduled Technical and Program Management Meetings
o Dashboards for Senior Management
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o Establish and Manage Clinical Supply Chain Logistics
o Define Commercial Supply Chain Logistics
o Commercial Product Inventory Planning
o Management of 3rd Party Testing Labs
o Management of 3rd Party Long Term Storage Facilities
o Cost-of-Goods Analysis
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o CMC, Non-clinical, and Regulatory Due Diligence Services
o Strategic Advice on Positioning Products or Technologies for In-Licensing or Out-Licensing