Service Offerings
Supply Chain
Commercial Readiness
Program Management
- Development of supply chain strategy
- Drafting of Requests for Proposal (RFPs) for external manufacturing opportunities
- Leadership of CDMO selection process
- Review and negotiation of Master Services Agreements, Quality Agreements, and Commercial Supply Agreements
- Oversight of external manufacturing network, including Drug Substance & Drug
- Development of supply chain strategy
- Drafting of Requests for Proposal (RFPs) for external manufacturing opportunities
- Leadership of CDMO selection process
- Review and negotiation of Master Services Agreements, Quality Agreements, and Commercial Supply Agreements
- Oversight of external manufacturing network, including Drug Substance & Drug Product CDMOs, and Clinical & Commercial CPOs
- Leadership of Joint Steering Committee (JSC) meetings
- Development and implementation of Sales & Operations Planning (S&OP) process
- Development of Cost of Goods Sold (COGS) estimates
Program Management
Commercial Readiness
Program Management
- Development and implementation of right-sized Program Management Office (PMO), consisting of the appropriate tools, team structure, escalatation process and governance to ensure effective and consistent management of programs throughout the organization
- Management of asset-level development teams and supporting sub-teams, including CMC an
- Development and implementation of right-sized Program Management Office (PMO), consisting of the appropriate tools, team structure, escalatation process and governance to ensure effective and consistent management of programs throughout the organization
- Management of asset-level development teams and supporting sub-teams, including CMC and clinical supplies
- Management of tech transfer and manufacturing projects for both the sponsor and CDMO
- Standard Program Management activities including development of timelines, budgets, action logs, decision logs, risk registers, etc.
Commercial Readiness
Commercial Readiness
Commercial Readiness
- Development of NDC numbering strategy
- Design of Commercial Packaging, including artwork, labeling and security features
- Packaging validation, including serialization integration at CPO
- Development of commercial infrastructure
- Commercial supply planning
- Negotiation of commercial supply and quality agreements