We deliver end-to-end Chemistry, Manufacturing and Controls (CMC) consultancy to ensure that drug substances, products, processes, and test methods are scientifically robust, reliable, and regulatory compliant.
Our knowledgeable CMC experts integrate seamlessly with client teams across all phases of development, from early research to postmarketing lifecycle management.
Early-stage companies seeking foundational CMC guidance to ensure their product, process, and analytical methods mature appropriately for regulatory interactions and initial clinical studies.
Teams advancing novel modalities, biologics, ATMPs or new chemical entities requiring phase appropriate method development, stability programmes, and technical oversight, appropriate method development, stability programmes, and technical oversight.
Organisations progressing products through clinical phases or post-approval, needing CMC strategy, GMP alignment, technology transfers, validation, and regulatory support.
We provide end-to-end CMC consultancy that ensures your drug substance, product, processes, and analytical methods are scientifically robust, reliable, and ready for regulatory submission—supporting you from early development through postmarketing activities.
This includes comprehensive coverage across product, process, and method development, stability studies, validation, GMP manufacturing/testing, and packaging solutions, giving you the expert guidance needed to confidently progress through every stage of development
We will work with you to guide you smoothly through each stage of CMC development, giving you clarity, confidence, and the expert support you need from start to finish.
We evaluate your current CMC package, including Target Product Profile, manufacturing routes, analytical coverage, and regulatory readiness.
Provide scientific and regulatory guidance to define a clear CMC strategy, including study design, execution, and coordination across stakeholders.
Support selecting optimal CDMOs in Europe, Asia, and the US through strategic, technical, and regulatory assessment
Support includes product formulation, process optimisation, method selection and development, qualification, validation, and technology transfer.
We design and evaluate product stability studies and carry out method qualification, validation and transfer activities
We can manage GMP audits, inspection readiness, CDMO document review (protocols, reports, SOPs), Technical and Quality Agreements and alignment with regulatory quality expectations.
We provide authoring and review of Quality Module content (e.g. CTD), supporting global submissions.
Our crossfunctional CMC capabilities provide comprehensive support across product, process, and analytical method development—ensuring your programme is scientifically robust and fully aligned with global regulatory expectations:
Integrated Expertise Across Disciplines
A highly qualified team of CMC specialists, regulatory experts, GMP professionals and technical leaders who integrate directly into client teams.
End-to-End Lifecycle Support
CMC support extends from early discovery through to post-marketing activities, ensuring continuity and consistency across the full development journey.
Hands-On, Multidisciplinary Collaboration
Our experts work within your development teams to accelerate product, process and analytical method development.
Regulatory Confidence
CMC is foundational to regulatory approval, and we ensure that all supporting data, test methods, stability packages and processes meet the expectations of global regulators.
CMC covers product, process and method development, stability studies, validation activities, GMP manufacturing/testing, and packaging development including combination devices.
CMC is relevant at every stage—early development, clinical phases, and postmarketing.
Yes, our CMC team seamlessly integrates into multidisciplinary client teams to accelerate development.
Yes, we author and review Quality Module content (e.g., CTD), CMC strategy documentation, and provides scientific/regulatory guidance.
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