Chemistry, Manufacturing, and Controls (CMC) Advice and Management

What is CMC Management?

CMC is an acronym for chemistry, manufacturing, and controls which are crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches. CMC begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development life cycle. In addition to the pharmaceutical product, CMC also applies to the facility where manufacturing occurs. 

What is the Purpose of CMC?

Before you’re ready to test your medicinal product on humans, you must develop a CMC process to ensure quality manufacturing standards have been established. This information is required in Module 3 of the clinical trials application (CTA), such as the investigational medicinal product dossier (IMPD) in Europe and the Food and Drug Administration’s (FDA’s) investigational new drug (IND) application in the US, as well as EU marketing authorization applications and FDA new drug applications (NDAs) or biologics license applications (BLAs).

The primary objective of CMC is to assure the quality of the finished product during all phases of development. Regulatory authorities need to see detailed standards to ensure consistency of identity, safety, quality, stability, and strength between the product used for clinical trials and product batches produced for commercial purposes on an ongoing basis.

Are CMC Practices Required?

All companies with investigational products are required to follow the specific details of their CMC process for every phase of the product lifecycle, including lifecycle management activities, eg, technology transfer and line extensions. A critical element is knowing which steps and variables in the manufacturing process need to be controlled and why in order to obtain a comprehensive understanding of the necessary CMC strategy.

Consequences of CMC Regulatory Non-Compliance

If CMC practices are not followed or if they do not meet current regulatory requirements, the marketing authorization will be considered non-compliant and will be withdrawn. The consequences of this include fines, suspension of distribution, and any data gaps will have to be addressed under scrutiny of the appropriate regulatory agencies.

Regulatory requirements are constantly evolving, so you’ll need to update your CMC strategy to stay compliant with current guidance from the agency.

Should You Work With a CMC Consultant to Develop Your Strategy? 

Working with a global partner experienced in regulatory strategy and CMC development can help you appropriately analyze and document the manufacturing processes, active substance and drug product characteristics, and testing to ensure the product is safe, effective, and consistent.

From early-stage development and at every point through commercialization, ProPharma partners with our clients to tackle complex CMC development challenges. We help ensure the regulatory authorities see the control and robustness of your process and product from a documentational and operational perspective. As your CMC consulting partner, we can smooth the path to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization, balancing cost, risk, and speed to help you ensure quality manufacturing and effective controls for the health and safety of patients.

Science-Focused Regulatory CMC Consulting Experts

At ProPharma, our regulatory CMC consulting experts are scientists first and foremost. Our team has decades of global regulatory and quality experience, allowing us to provide a unique level of service when developing your Chemistry, Manufacturing, and Controls plan:

• Our unmatched global reach means we can work with you to prepare your marketing applications (MAA or NDA) in parallel, saving you time and money
• Our science-first approach to understanding your product, combined with first-hand insights of regulatory expectations and requirements, help support the successful design of your CMC plan — including process and formulation development, analytical development identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP), developing control strategies, establishing quality testing methods and reviewing validation protocols and reports
• Our 35+ years of providing regulatory sciences services means we’ve seen how submission requirements and expectations are constantly evolving. Our frequent contact and extensive experience with regulatory agencies ensure you will be following the latest FDA and European Medicines Agency (EMA)/national agencies guidance
• Our understanding of the regulatory world means that we can interpret the regulatory landscape and translate this into a successful regulatory CMC strategy. We can also provide scientific advice and prepare, coordinate, and participate in meetings with the regulators of interest
• Our unique standing as a single-source provider of regulatory, life science consulting (including quality assurance), pharmacovigilance, and medical information services offers you a cohesive, multidisciplinary extension of your team through every phase of the product lifecycle

Contact our Chemistry, Manufacturing, and Controls (CMC) management consultants experts to learn how we can help you through the entire product development lifecycle, from candidate selection to post approval and beyond.

Our CMC consulting services can be tailored to your needs. Whether you need guidance developing your CMC strategy, assistance with submissions, or advice on post-launch improvements — we’re here to help.