Chemistry, Manufacturing & Controls (CMC) Consultancy

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.  

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Our Expertise

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 post marketing lifecycle management.

  • CMC activities ensure products are safe, effective, and consistent between batches, supporting regulatory approval.
  • We supports all stages of the product lifecycle, including early, late, and (post) marketing phases.
  • Broad coverage of CMC domains, including test methods, stability testing, validation, packaging, and GMP manufacturing/testing. As well as medical device regulations and notified body requirements for drug–device combination products.
  • Delivered by a diverse team of Project Managers, Technical Leaders, CMC Regulatory Specialists and GMP experts.
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Our CMC Consultancy supports the full spectrum of life sciences organisations:

Start-ups

Early‑stage companies seeking foundational CMC guidance to ensure their product, process, and analytical methods mature appropriately for regulatory interactions and initial clinical studies. 

Biotech Companies

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.

 

Pharmaceutical Companies

Organisations progressing products through clinical phases or post‑approval, needing CMC strategy, GMP alignment, technology transfers, validation, and regulatory support.

CMC Brochure 2

CMC Consulting Service

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 post‑marketing 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.

1. Assessment & Gap Analysis

We evaluate your current CMC package, including Target Product Profile, manufacturing routes, analytical coverage, and regulatory readiness.

2. Strategy & Roadmap Development

Provide scientific and regulatory guidance to define a clear CMC strategy, including study design, execution, and coordination across stakeholders.

3. CDMO selection

 Support selecting optimal CDMOs in Europe, Asia, and the US through strategic, technical, and regulatory assessment

4. Development & Optimisation

Support includes product formulation, process optimisation, method selection and development, qualification, validation, and technology transfer.

5. Stability & Validation Programmes

We design and evaluate product stability studies and carry out method qualification, validation and transfer activities

6. GMP & CDMO Oversight

We can manage GMP audits, inspection readiness, CDMO document review (protocols, reports, SOPs), Technical and Quality Agreements and alignment with regulatory quality expectations.

7. Regulatory Submission Support

We provide authoring and review of Quality Module content (e.g. CTD), supporting global submissions.

Our CMC Consulting Capabilities

QbD

Quality by Design

Including risk assessments and Design‑of‑Experiments (DoE) study design.

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GMP audits

And inspection readiness activities to ensure compliance with global regulatory expectations.
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API

API–excipient compatibility studies and development of early‑phase “fit for purpose” formulations, supporting drug‑substance and drug‑product profiling.
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Formulation

Formulation development for parenterals, oral solid dosage forms, and lyophilised products.
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Release

Modified release technologies, including immediate, delayed, and prolonged release formulations.

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Packaging

 Packaging selection, including combination medical devices, ensuring compatibility and regulatory ready configuration. 
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Method

Analytical method development, qualification, validation, and transfer for robust and reliable product testing.
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Stability

 Product stability study design and execution, supporting shelf‑life definition and regulatory filings. 
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AMTP

ATMP (Advanced Therapy Medicinal Product) development support, including preparation of ATMP‑specific development plans.

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Why Choose hVIVO

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.

FAQ

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 post‑marketing.

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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