CMC Regulatory Strategy – areas of work

CMC, or Chemistry, Manufacturing, and Controls, is the process of obtaining regulatory approval from regulatory bodies for pharmaceutical products. CMC regulatory strategy gives strategy and leadership needed to achieve regulatory approval.

In going ahead with its work of helping a pharma company obtain regulatory approval, CMC regulatory strategy goes about in its own set method. This is the two-stage process in which CMC regulatory strategy works:

Regulatory Documentation Changes through Product Approval: This lies at the heart of CMC regulatory strategy. For any company that needs to get a product approval, it has to adapt a regulatory strategy that retrospectively, continuously and prospectively tracks the progressive, regulatory requirements in detail. This tracking could be from all stages starting from the initial clinical trial, pre-registration, registration, post-approval, and life cycle management.

Post Approval: The work of CMC regulatory strategy does not end with product approval. In fact, it is important for it to implement changes that are required for the system, and to maintain records of all the revisions and changes that have been carried out into the product. CMC regulatory strategy has to also maintain the lifecycle of the approved pharmaceutical product. Another very important aspect of CMC regulatory strategy is that it has to maintain an efficient and effective change control process. This is very important and essential if product conformance and compliance are to be ensured and maintained.



Contact Detail

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801


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