What is CMC in the Drug Development Process? 

In the complex world of drug development, one critical function helps ensure the bridge between drug discovery and patient access: CMC—Chemistry, Manufacturing, and Controls.  

CMC deficiencies account for approximately 20% of non-approval decisions for marketing applications.¹ While often underappreciated in early development, CMC is a cornerstone for regulatory success, safety, and commercial scalability.

So, what exactly is CMC, and why should we prioritize it from day one? 

Table of Contents

• What Does CMC Mean in Drug Development?
• What Is the Role of CMC in Drug Development?
• What is the Role of CMC in the Early Phase of Drug Development?
• Best Practices for CMC Success

Article Summary

• CMC=Chemistry, Manufacturing, and Controls—these are crucial activities that help ensure your drug is safe, consistent, and regulatory-ready
• CMCs include many activities that define the manufacturing process, quality control to meet product specifications, drug formulation and stability studies
• CMC is required for Investigational New Drug (INDs), Non-disclosure Agreements (NDAs), and global regulatory filings
• Starting CMC planning early in development can help prevent costly delays
• Biotech companies may choose to collaborate with CDMOs to handle their CMC documentation, validation, and GMP manufacturing
• It’s not just paperwork—strong CMCs=faster approvals and better scalability

What Does CMC Mean in Drug Development? 

CMC refers to the technical and regulatory documentation that supports the identity, quality, purity, strength, and consistency of a drug product throughout its lifecycle. 

At its core, CMC includes: 

• Drug substance (API): structure, characterization, manufacturing process
• Drug product: formulation, stability, packaging, container-closure systems
• Analytical methods: used to confirm identity, purity, strength and potency
• Manufacturing controls: batch records, scale-up process, QA/QC protocols 

In short, CMC is about proving your drug is reliably made using a producible, scalable, process, and is safe to give to patients. 

What Is the Role of CMC in Drug Development? 

Failing to have robust CMC data can lead to delays in regulatory submissions or derail the approval of a drug at critical milestones.  

Key reasons to prioritize CMC include: 

• Regulatory expectations: CMC information is required for INDs, NDAs, BLAs, and EU MAAs
• GMP compliance: CMC supports quality management and manufacturing audits
• Tech transfer: Smooth handoffs from process development to manufacturing and commercialization depends on robust CMC data

A well-planned CMC can help shorten timelines and increase the likelihood of regulatory success.

CMC in Drug Development Phases

Phase	Focus
Process Development & Optimization	Solutions and technologies helped streamline your cGMP process, drug substance and drug product development, and advance candidates
Pre-Clinical	Analytical methods,   API and formulation development, pre-clinical PK/PD and other analytical analyses to help determine if a drug candidate is safe to test in humans
Clinical Trials Phase I – III	Scale-up, impurity profiles, stability testing  Full-service clinical research and manufacturing coupled with asset, logistics and regulatory management to navigate clinical trial, Process validation and GMP readiness
Commercialization	Market access, commercial manufacturing, supply chain management, global distribution to help drive value and life cycle management

Each phase builds toward a more robust and compliant CMC dossier, particularly the Common Technical Document (CTD) Module 3. 

What is the Role of CMC in the Early Phase of Drug Development? 

The drug development process is often rife with various challenges and roadblocks. The availability of robust analytical methods to assess identity, strength, purity, potency, and stability is important throughout all stages of drug development.  

These include: 

• Compressed timelines that may lead to process de-prioritization
• Evolving formulations that may trigger change controls
• Global regulatory divergence across FDA, EMA, PMDA, etc.
• Each regulatory body—FDA, EMA, and PMDA—places a strong emphasis on CMC to help ensure drug quality and safety. Recent regulatory changes reflect a global trend towards the adoption of advanced manufacturing technologies, risk-based approaches, and harmonization of post-approval change management. Staying abreast of these changes and aligning CMC practices accordingly is crucial for achieving regulatory success and ensuring timely drug development
• Scaling complexity from clinical to commercial batches

It is best practice to start building your CMC plans early. It’s also helpful to consider outsourcing to experienced CDMO partners who can provide guidance, regulatory-ready documentation and GMP production services.

Best Practices for CMC Success

• Initiate CMC planning during preclinical stages
• Align lab workflows with scale-up and validation needs
• Implement risk-based quality management systems (QMS)
• Choose CDMO collaborators with integrated analytical, regulatory, and manufacturing capabilities
• Build CMC into your cross-functional product development roadmap 

CMC is not simply about compliance—it’s about building a foundation for quality, safety, and success.  

For lab researchers and biotech innovators, understanding and integrating CMC strategy early can help accelerate the path to approval and help ensure scalability from first dose to full market launch. 

Looking for support in your CMC strategy?

Explore how Thermo Fisher Scientific supports drug development with end-to-end CDMO and CRO solutions.

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Citations

Wills CA, Drago D, Pietrusko RG. Clinical holds for cell and gene therapy trials: Risks, impact, and lessons learned. Mol Ther Methods Clin Dev. 2023 Dec;31:101125. PubMed PMID: 37886603.