CMC Regulatory Documentation Authoring

CMC (Chemistry, Manufacturing, and Controls) regulatory documentation authoring services in the pharmaceutical industry refer to the preparation and writing of technical documents that describe the process and quality control measures of drug development and production. This documentation is necessary for regulatory agencies such as the FDA to approve a new drug and monitor its manufacturing processes. 

The CMC documentation includes information such as the composition of the drug, manufacturing process, stability studies, analytical methods, and quality control procedures. CMC Regulatory Documentation Authoring refers to the process of creating and compiling the necessary documents for submission to regulatory agencies as part of a pharmaceutical product’s marketing approval application. This information is critical for demonstrating to regulatory agencies that the product is safe, effective, and suitable for its intended use.

Our team of experienced regulatory writers has a deep understanding of the requirements for CMC (Chemistry, Manufacturing, and Controls) documentation, including Common Technical Documents (CTDs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).

We deliver our writing and submission services with the following principles:

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Our CMC Regulatory Documentation Services

With increasing regulatory complexity across global markets, company expansions with mergers and acquisitions, Market Authorization Holders (MAH) are expected to fulfill compliance requirements around Chemistry, Manufacturing, and Controls (CMC). Our team of Medical Writers and Regulatory Professionals have extensive experience in supporting sponsors with the following needs:

  1. IND (Investigational New Drug) Application: Prepare and complete regulatory submission to the FDA with information on the proposed clinical trial, the drug substance and product, and the manufacturing process. It is required before a drug can be tested in humans.

  2. Drug Master File (DMF): Document detailed information about the manufacturing, processing, packaging, and storage of a drug substance or drug product. 

  3. BLA (Biologics License Application): Complete BLA submission to the FDA to provide information on the safety, efficacy, and quality of a biological product. 

  4. CTD (Common Technical Document): Complile eCTDs for submitting information to regulatory agencies on the details of the the drug composition, scientific product information, and clinical studies, as well as information on the manufacturing process.

  5. GMP (Good Manufacturing Practices) documentation: This includes documents related to the manufacturing process, such as standard operating procedures (SOPs), batch records, validation protocols, and stability data.

  6. Stability data: Documents which have information about the stability of the drug product under various storage conditions.

  7. Process validation data: Documents that describe the validation outcomes of the entire manufacturing process including details on material, method, instruments, and facilities.

  8. Analytical method validation data: Analytical method validation data is required to demonstrate that the analytical methods used to test the drug substance and drug product are accurate, precise, and reliable.

  9. Container closure system information: This includes information on the packaging and labeling of the drug product, as well as information on the container closure system, such as the container, closure, and stopper.

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The CMC regulatory documentation typically needs to be submitted to regulatory agencies, such as the FDA, as part of a new drug application (NDA) or an abbreviated new drug application (ANDA), depending on the type of product being submitted. The submission timeline may vary depending on the regulatory requirements and the type of submission being made. 

In general, the CMC regulatory documentation should be submitted as early as possible in the drug development process to ensure that the regulatory review process can proceed as smoothly and efficiently as possible.

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