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We provide the technical leadership and strategic foresight needed to bridge the gap between discovery chemistry and GMP manufacturing. Whether you need a Fractional Head of CMC or targeted problem-solving, we ensure your program is ready for the rigors of regulatory review.
Why Partner with HIL CMC?
Why Partner with HIL CMC?
Reduce Technical Risk: Identify scale-up issues before transferring to a CDMO.
Accelerate Timelines: Execute "right-first-time" tech transfers to avoid batch failures.
Optimize Spend: distinct "Phase-appropriate" strategies that save capital during early development.
Comprehensive CMC Capabilities
Comprehensive CMC Capabilities
Process Development & Scale-Up
Process Development & Scale-Up
Turning bench-scale chemistry into a robust manufacturing process. We design scalable synthetic routes, optimize reaction parameters, and manage scale-up from grams to 100+ kg. We focus on efficiency, safety, and process understanding (DoE/QbD) to ensure reliable API supply.
External Manufacturing Leadership
External Manufacturing Leadership
Acting as your virtual site head for global supply chain management. We handle the entire CDMO lifecycle: from selecting the right partner and negotiating technical contracts to overseeing tech transfer, validation, and on-site GMP production. We ensure your external partners deliver on time and on quality.
CMC & Regulatory Strategy
CMC & Regulatory Strategy
De-risking the path to IND and NDA approval. Comprehensive regulatory support, including phase-appropriate control strategies, risk assessments, and authoring of Module 3 (Quality) sections. We ensure your data package meets FDA/EMA expectations and stands up to scrutiny.
Due Diligence & Technical Assessment
Due Diligence & Technical Assessment
Independent, rigorous evaluation for investment and licensing decisions. We provide unbiased technical assessments for venture funds and biotechs. Whether evaluating a potential asset for acquisition or preparing your own data room for partnership, we identify the technical risks others miss.
Engagement Models
Engagement Models
Flexible Engagement Models We tailor our support to the size and stage of your organization.
Fractional CMC Leadership:
Ongoing, embedded leadership acting as your internal "Head of CMC" or "VP of Manufacturing."
Project-Based Support:
Targeted execution for specific milestones (e.g., CDMO Selection, IND Filing, Route Optimization).
Advisory & Diligence:
Short-term consulting for technical assessments, gap analyses, and investment reviews.
Ready to Accelerate Your Development Program?
Ready to Accelerate Your Development Program?
Let’s discuss your current development challenges and map out a strategy for commercial success.
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