Chemistry, manufacturing and controls (CMC), refers to the set of regulatory documentation that describes how a drug product is developed, manufactured, tested and controlled. CMC content forms a critical part of regulatory submissions across clinical and commercial stages, and must accurately reflect actual development and manufacturing activities to support successful regulatory review.
Regulatory success depends on robust CMC documentation that accurately reflects how a product is developed, manufactured and controlled. Gaps between development activities and regulatory submissions can lead to delays, additional health authority queries and compliance risk – particularly as programs move through clinical phases and toward commercial supply.
We provide CMC and regulatory support focused on drug product development and manufacture. Working alongside sponsor regulatory teams, we support the preparation of phase-appropriate CMC content, maintain GMP compliance and help ensure your product and documentation remain aligned as your program progresses from early clinical phases through to commercial supply.
Strengthen alignment between development, manufacturing and regulatory documentation
- Apply phase-appropriate CMC strategiesWe help ensure CMC activities and documentation evolve in line with development stage, product type and regulatory expectations.
- Strengthen submission readinessCMC documentation support for IND and IMPD submissions helps reduce gaps, rework and clarification requests during regulatory review.
- Maintain GMP compliance with confidenceGMP auditing, certification and oversight support inspection readiness as manufacturing processes and controls develop.
- Address additional regulatory complexityExperience supporting controlled drugs, highly potent products, veterinary medicines and specials helps manage additional licensing and compliance requirements.
- Maintain documentation consistency across the lifecycleEmbedded support across development and manufacturing helps ensure consistency between your product, your processes and your regulatory documentation as programs evolve.
Why SGS?
As the world's leading testing, inspection and certification company, we combine our Contract Development and Manufacturing Organization (CDMO) manufacturing expertise with in-depth experience in quality, testing and certification. Our CMC and regulatory support is embedded within our development and manufacturing services, helping ensure consistency between your product, your processes and your regulatory documentation.
This integrated approach delivers the structure, credibility and regulatory awareness needed to support complex development programs – from early clinical submissions through commercial life cycle management.
FAQ
Phase-appropriate CMC means tailoring the depth, scope and formality of CMC documentation to the requirements of each development stage. Early clinical submissions require less extensive CMC content than commercial filings, but documentation must still be robust, compliant and consistent with development activities. We help ensure CMC strategies evolve in line with stage, product type and regulatory expectations.
We support the preparation of phase-appropriate CMC content for Investigational new drug (IND) applications and investigational medicinal product dossier (IMPD) submissions. This includes documentation aligned to development and manufacturing activities, helping reduce gaps, rework and clarification requests during regulatory review.
GMP compliance and CMC documentation are closely linked. CMC content must accurately reflect manufacturing processes and controls, which in turn must meet GMP requirements. Our GMP auditing, certification and oversight services support inspection readiness as manufacturing processes and controls develop, helping maintain compliance across the program life cycle.
Yes. Our experience covers products with additional regulatory complexity, including controlled drugs, highly potent products, veterinary medicines and specials. We help manage the additional licensing, handling and compliance requirements associated with these product categories.
No. We work alongside sponsor regulatory teams to support CMC content preparation, GMP compliance and documentation alignment. Our role is to provide CDMO-side regulatory and CMC expertise that complements your internal regulatory function – not to replace strategic regulatory ownership, which remains with you.
Our CMC and regulatory support is embedded within our development and manufacturing services. This integration helps ensure consistency between your product, your processes and your regulatory documentation as your program progresses – reducing the risk of misalignment between development activities and regulatory content.
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