In the pharmaceutical industry, CMC stands for Chemistry, Manufacturing, and Controls. It is the process of ensuring that a drug product is safe, effective, and of high quality. CMC activities span the entire drug development lifecycle, from preclinical research to post-market surveillance.

In the context of regulatory affairs, CMC refers to the information that must be submitted to regulatory agencies to obtain approval for a drug product. This information includes detailed descriptions of the drug substance, the drug product, the manufacturing process, and the quality control procedures. Regulatory agencies use this information to assess the safety, efficacy, and quality of the drug product.

CMC regulatory affairs is a critical function in the pharmaceutical industry. It helps to ensure that safe, effective, and high-quality drug products are available to patients. The CMC certification assures each batch of drug, irrespective of its time and place of manufacture conforms to prescribed standards of strength, identity, quality and purity.

The CMC activities are complex due to the abundance of data and documentation required, and mismanagement of these processes with the regulatory bodies can result in delays to submissions, or non-compliance, and ultimately a delay to the launch of innovative medicines.

Our CMC Services Include:

  • CMC Strategy Development and Implementation

  • CMC Regulatory Submissions

  • CMC Quality Assurance and Compliance

  • CMC Risk Assessment and Mitigation

  • CMC Training and Education

  • CMC Literature Review and Analysis

  • CMC Regulatory Gap/Impact Assessment

  • CMC Documents authoring/co-authoring

  • CMC Dossier Development

  • CMC Clinical Trial Support

  • CMC Post-Market Surveillance

Additional Information

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Pharmaceutical Industry Regulatory Affairs - Celegence

Celegence CMC Services 

Celegence provides a comprehensive suite of CMC services to ensure the processes are carried out smoothly and meet the requirements of the different regulatory bodies, to support help our clients to bring their drug products to market safely and efficiently.

Our clients can benefit from our:

  • Deep understanding of CMC regulations and the regulatory processes

  • Experience of working with different regulatory agencies around the world

  • Team of experts with a proven track record of success

  • Access to global resources and expertise

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How to Get Started with Celegence CMC Services

To get started with Celegence CMC services, please contact us today. We would be happy to discuss your specific needs and provide you with a quote.

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