CMC Regulatory Strategy
CMC stands for Chemistry, Manufacturing, and Controls. It is a critical and indispensable area of regulatory affairs. Why this is so is because CMC is concerned with the strategy and planning of obtaining regulatory approval. So, CMC regulatory strategy is the means that take a product towards regulatory approval. For any company to conduct clinical investigations and market pharmaceutical products; getting regulatory approval from the regulatory authorities of the respective countries is a legally binding requirement.
Means to getting regulatory approval
It is the responsibility of CMC regulatory strategy to provide strategy, direction and leadership needed for helping companies achieve regulatory approval. Being a critical strategic function; CMC regulatory strategy interacts at multiple levels and layers of a company and also with external agencies to help a company achieve its regulatory approval.
Several areas of collaboration
Science, techniques, technology, quality and commerce are some of the areas CMC regulatory strategy works with within the company. From outside, its areas could include contract Manufacturing Organizations (CMO’s), when the organization has chosen this kind of manufacturing.
How does it help?
How does CMC regulatory strategy work?CMC regulatory strategy makes companies get, comprehend,infer and develop regulatory guidances and regulations. It also helps them with supplying and adapting industry and government agency best practices and trends.
Let us say a company wants to manufacture a new API. In such a case;these could be some of the submissions CMC regulatory strategy could help the company with:
- Analytical methods and specifications used for testing and release of raw materials, in-process controls, container and closure systems, API and the dosage form
- Characterization of the API and composition of the dosage form
- Description of the manufacturing processes
- Description of the product and process development
- Names and locations of manufacturing and testing sites
- Raw materials used to manufacture the API and finished dosage form
- Release and stability testing data for both the API and the dosage form.
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