What is the CMC?
In the pharmaceutical industry, the three Cs of CMC stand for chemistry, production, and controls. Additional standards and criteria must be adhered to assure product safety and uniformity across batches, which are referred to be “CMC.” CMC starts with the identification of a lead chemical and continues throughout the rest of the drug development process. CMC include both the medicine itself as well as the facility in which it is produced.
What is CMC’s primary goal?
A quality manufacturing process (CMC) must be in place before you can begin testing your pharmaceutical product on people. Clinical trials application (CTA) Module 3 requires this information, which includes the investigational medicinal product dossier (IMPD) in Europe, the FDA’s investigational new drug (IND) application in the United States, and EU marketing authorization applications and FDA new drug applications (NDAs) or biologics licenses applications. This information is required in Module 3. (BLAs). The major goal of CMC is to ensure the quality of the end product throughout the development process. Product batches for commercial use and clinical studies must be identical in terms of identity, safety, quality, stability, and strength in order to meet regulatory requirements.
How important are CMC methods?
For every point of the product lifecycle, including technology transfer and line expansions, all firms with investigational goods must follow the precise specifics of their CMC. In order to fully comprehend the manufacturing process and the appropriate control strategy, it is essential to know which phases and variables within the process need to be managed and why. The marketing authorisation will be revoked if CMC procedures are not followed or if current regulatory standards are not met. In addition to the penalties and suspension of distribution, regulatory authorities will be looking into any data gaps that may exist.
Are Consultants Necessary for the Development of Your CMC Plan?
In order to make sure your product is safe, effective, and consistent, you should work with a worldwide partner that has expertise in regulatory planning and CMC development.
ProPharma Group collaborates with our customers to overcome significant CMC issues, beginning with the early stages of research and continuing all the way through commercialization. From a documentation and operational viewpoint, we assist guarantee that the regulatory authorities understand the control and robustness of your process and product are well documented. To guarantee patient safety and excellent manufacturing as well as effective controls, we can work with you as your CMC partner to ease the route to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization.
Science-Focused Regulatory CMC Experts
Our regulatory CMC specialists at ProPharma Group are first and foremost scientists. In establishing your Chemistry, Manufacturing, and Controls strategy, our PhDs and MDs have decades of worldwide regulatory and quality expertise, enabling us to give a unique level of service.
- Your marketing applications (MAA or NDA) may be prepared at the same time, saving you both time and money.
- A combination of our focus on science and our in-depth knowledge of regulatory expectations and requirements enables us to assist you in developing an effective CMC strategy, which includes the development of processes and formulations, analytical development, identification of critical quality attributes (CQA), development of control strategies, establishment of quality testing methods, and evaluation of validation protocols.
- Regulatory science services have evolved significantly during the last three decades because of our extensive experience. It is because of our close ties to the FDA and the European Medicines Agency (EMA) that we are able to keep up with the most recent regulatory recommendations.
- A thorough awareness of the regulatory environment enables us to transform this into an effective regulatory CMC strategy based on this knowledge. As a further service, we may prepare for and participate in meetings with relevant authorities by offering expert scientific advice.
- When it comes to regulatory and life science consultancy (including quality assurance), pharmacovigilance, and medical information service providers, we are a one-stop shop for all of your product lifecycle needs.
