External Manufacturing Leadership
Your "Virtual Site Head" for Global Supply Chain Management
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For emerging biotechs, the CDMO (Contract Development & Manufacturing Organization) is your factory. But signing a contract doesn't guarantee success. We act as your internal manufacturing lead, managing the complex relationship between your scientific goals and the CDMO’s operational realities.
From vendor selection to batch release, HIL CMC Consulting provides the oversight needed to ensure your drug is made to the highest quality standards—on time and on budget.
Our Technical Capabilities
Our Technical Capabilities
Strategic Selection & Contracting
Strategic Selection & Contracting
Finding the "right fit" partner is half the battle. We move beyond the glossy marketing decks to evaluate technical fit, capacity, and quality culture.
CDMO Evaluation: rigorous auditing of capabilities and compliance.
RFP Management: Drafting detailed Requests for Proposals to compare apples-to-apples.
Contract Negotiation: Reviewing MSAs and SOWs to protect your IP and budget.
Technical Transfer & Readiness
Technical Transfer & Readiness
The hand-off from your lab (or a CRO) to a GMP facility is the highest risk point in development. We manage this bridge.
Tech Transfer Leadership: Ensuring data packages are complete and robust.
Gap Analysis: Identifying equipment or process mismatches before they cause delays.
Batch Record Review: Detailed scrutiny of manufacturing instructions.
Person-in-Plant & Oversight
Person-in-Plant & Oversight
We provide the vigilance that busy internal teams often lack.
Project Management: Driving timelines and holding vendors accountable.
Problem Solving: Real-time troubleshooting of deviations and OOS (Out of Specification) results.
Supply Chain Security: Managing raw material sourcing and inventory risks.
The "HIL" Difference
The "HIL" Difference
We Don't Just "Monitor." We Manage.
We Don't Just "Monitor." We Manage.
A passive consultant forwards emails. An active leader anticipates problems. We leverage decades of experience to ask the tough questions, challenge CDMO excuses, and drive the project as if we were your full-time VP of Technical Operations.
Typical Outcomes
Typical Outcomes
Reduced Timeline Risk:
Preventing "start-stop" delays during tech transfer.
Operational Continuity:
A seamless transition from lab to pilot to GMP production, eliminating the "knowledge gap" that typically occurs between phases.
Cost Control:
Avoiding change orders through tighter initial scope definition.
Quality Assurance:
Ensuring the final product meets all regulatory specifications for clinical use.
Explore Other Services
Explore Other Services
Looking for more? Explore our other core capabilities:
Looking for more? Explore our other core capabilities:
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