Build CMC compliance that lasts as long as your products do
CMC strategy and documentation shape a product from early development through the marketing authorization application dossier, then continue through change control and maintenance for as long as the product stays on the market.
Requirements differ for chemicals, biologicals, biosimilars, and herbal and homeopathic products, and they keep evolving. Cencora helps you choose the right CMC approach for each product, meet health authority requirements, and keep compliance sustainable as your portfolio grows.
For specialized support, explore our dedicated CMC small molecule and CMC biologics solutions.
Requirements differ for chemicals, biologicals, biosimilars, and herbal and homeopathic products, and they keep evolving. Cencora helps you choose the right CMC approach for each product, meet health authority requirements, and keep compliance sustainable as your portfolio grows.
For specialized support, explore our dedicated CMC small molecule and CMC biologics solutions.
Stay ahead of what puts hard-won approvals at risk
Mergers, expanding manufacturing networks, and stretched internal processes all put CMC compliance under strain, with consequences that range from delayed approvals to recalls and lost marketing authorizations.
Mergers and acquisitions
Integration reshuffles products, sites, and dossiers faster than documentation can follow, leaving gaps between what is filed and what is made.
Complex manufacturing networks
Internal and external sites multiply hand-offs and interfaces, and every hand-off is a chance for change control to slip.
Stretched internal processes
Teams built for a simpler portfolio struggle to manage today’s complexity, so issues surface in inspections rather than internal reviews
Global CMC support across development, approval, and maintenance
You get one multidisciplinary team for CMC strategy, scientific and technical writing, and submission management, covering every region where you file.
That team supports chemicals, biologicals, biosimilars, and herbal and homeopathic products, and works to the latest health authority requirements at every stage of the lifecycle.
That team supports chemicals, biologicals, biosimilars, and herbal and homeopathic products, and works to the latest health authority requirements at every stage of the lifecycle.
What we offer
Regulatory CMC strategy
Strategic guidance through pharmaceutical development and lifecycle management, keyed to the regions and authorities your products answer to.
Scientific and technical writing
CMC authoring for quality dossiers and regulatory documents, from development reports through the marketing authorization application dossier.
Quality dossier compilation
ICH and non-ICH quality dossiers, including CTD Modules 3 and 2.3, investigational dossiers, active substance master files, and certificates of suitability.
Intelligence and data management
Regulatory CMC intelligence and data management that keep specifications, methods, and commitments current across your whole portfolio
Change control and variations
Maintenance support for change control and quality variations, keeping approved dossiers aligned with manufacturing reality throughout the lifecycle.
GxP audits and compliance
Audit and compliance services across good manufacturing, distribution, and agricultural and collection practices, with remediation support where gaps appear.
Expert insight
The message was consistent: innovation cannot replace control. Robust data, validated methods, and sound documentation remain the cornerstone of regulatory reliability.
— Michael Day, PhD
RAPS Convergence 2025: Transparency, Trust, and Resilience in Regulatory Science
Related solutions
PharmaLex is now Cencora
CMC services is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about CMC services?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.