Advisory Services

Designing and managing external manufacturing networks to ensure reliable, scalable commercial supply.

When we engage:

• Preparing for commercial launch without established manufacturing infrastructure

• Underperforming CDMO relationships impacting timelines or supply

• Establishing governance, oversight, and performance management across global partners

Core capabilities:

• CDMO selection, evaluation, and onboarding strategy

• Governance frameworks and operating models

• Performance management and KPI development

• Technical and operational oversight

• Supply agreement strategy and negotiation

Leading CMC strategy and execution to transition products from development into reliable commercial supply.

When we engage:

• Transitioning from Phase 2/3 into commercial readiness

• CMC strategy misaligned with commercial manufacturing requirements

• Accelerated timelines requiring disciplined execution

Core capabilities:

• CMC strategy development and alignment

• Development to commercial transition strategy and planning

• Process validation strategy

• Regulatory CMC strategy and execution

• Cross-functional leadership across Quality, Regulatory, and Supply Chain

Executing technology transfers and ensuring readiness for reliable, sustained commercial supply.

When we engage:

• Transferring processes between CDMOs or from internal to external manufacturing networks

• Preparing for commercial launch or scale-up execution

• Delays or issues during transfer execution impacting timelines or supply

Core capabilities:

• Tech transfer planning and execution

• Process scale-up and validation strategy and execution

• Site readiness and operational alignment across manufacturing and quality functions

• Transfer risk assessment and mitigation planning

• Risk identification and mitigation

• Troubleshooting during transfer execution and startup

Providing experienced operational leadership to drive manufacturing, CMC, and supply chain performance.

When we engage:

• Gaps in internal leadership across technical operations or supply chain

• Need for experienced leadership during critical decision-making phases

• Organizational scaling, restructuring, or operating model redesign

Core capabilities:

• Interim leadership across technical operations and supply chain

• Strategic advisory to executive leadership teams

• Organizational design and operating model development

• Cross-functional leadership and alignment

• Decision support during high-risk execution and commercialization

• Building and leading technical operations organizations from the ground up

Providing investors with operational diligence and execution oversight across portfolio companies.

When we engage:

• Evaluating manufacturing scalability and risk pre- and post-investment

• Portfolio companies lacking experienced technical operations or supply chain leadership

• Identifying and mitigating manufacturing and supply chain risk

Core capabilities:

• Technical and operational due diligence

• CDMO evaluation, governance assessment, and risk identification

• Manufacturing scalability and readiness assessment

• Portfolio company execution oversight and advisory

• Value creation through operational improvement and supply chain performance

• Rapid assessment and stabilization of at-risk manufacturing and supply operations

Stabilizing supply and restoring performance in underperforming manufacturing networks.

When we engage:

• Recurring deviations, batch failures, or persistent quality issues

• Missed delivery timelines or sustained supply disruptions

• Lack of clear root cause or ineffective remediation strategies

Core capabilities:

• Root cause investigation and resolution of complex manufacturing issues

• CDMO performance recovery strategy and execution

• Deviation and CAPA strategy and execution

• Supply stabilization and continuity strategy

• Ongoing oversight, performance management, and stabilization tracking

• Rapid stabilization of at-risk supply chains and manufacturing operations