Creating CMC (Chemistry, Manufacturing, and Controls) documentation requires a deep understanding of technical and regulatory aspects.Every stage of a product’s lifecycle, from development to post-marketing updates, demands specialized expertise. Crafting high-quality CMC documentation can be challenging.
Celegence provides comprehensive support in authoring and reviewing CMC technical packages. Our extensive experience spans preparing and reviewing documents for briefing packages, IND/IMPD and MAA/BLA submissions, as well as post-approval variations and amendments. This expertise is demonstrated by our numerous successful submissions and positive regulatory outcomes.
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Celegence supports pharmaceutical manufacturers with the full scope of medical and technical writing services.Our proficiency covers a wide range of products, including small molecules, generics, biologicals, biotechnology-derived products, biosimilars, ATMPs, and vaccines.Our CMC Technical Authoring services are designed to support pharmaceutical manufacturers in creating comprehensive, accurate, and compliant documentation that meets regulatory requirements.
Medical Writing Services
Image Publishing and Submission Services
M2, M4, and M5 documents nonclinical and clinical overviews, summaries, study reports, integrated summaries
Literature review
SmPC, Pack Inserts, Product Rationale, PDR
Dossier writing & updates (CTD/eCTD)
CMC Authoring for MAA, NDA, IND and BLA, IMPD
Labeling and related updates – PIL, CCDS
Translation services with proof reading
RPM, PSUR, DSUR Authoring
Our proprietary cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers. It allows you to share, view, and review eCTD, NeeS, and other dossier formats from any region and access them in any location.
The hybrid solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud.
CMC Technical Authoring involves the creation of content on chemistry, manufacturing, and controls of drug substances and drug products, typically part of Module 2.3 and Module 3 of CTD.
These modules contain comprehensive information about the development, manufacturing, and control of process parameters (CPP) and quality attributes (CQA) of the pharmaceutical product as defined in ICH M4Q guidance documents.
The information is split across multiple sections to capture information about composition, manufacturing process, in-process checks, and analytical methods.
Describes the structure, properties and characteristics of the active pharmaceutical ingredient. Additional information on the synthesis / extraction process, impurity profile, analytical methods used for characterization or any pharmacopeial reference for testing methods.
Describes the final product that includes other components along with active ingredient like excipients, colorants, coating agents, binders, etc., The formulation, dosage form, and specifications for each ingredient is well structured and unambiguously documented.
The description of the drug’s manufacturing process is a central element of the CMC section. This includes information on equipment used, critical process parameters, and controls implemented to ensure consistency and quality.
Critical steps and intermediates in the manufacturing process are identified, and controls are established to monitor and regulate these elements. This ensures that the final product consistently meets the desired quality attributes.
Specifications define the acceptable ranges for various quality attributes of the drug substance and drug product. These include physical and chemical characteristics, potency, purity, and stability criteria.
The CMC section details the analytical methods used to assess the quality of the drug at different stages of development and production. This includes validation data demonstrating the reliability and accuracy of these methods.
Comprehensive stability studies are conducted to assess the drug product’s stability over time under various conditions. This information is crucial in determining the product’s shelf life and storage recommendations.
avigating the FDA drug approval process can be complex and demanding.
At Celegence, our CMC Technical Writing services are essential at every stage, from pre-clinical studies to Phase IV. Our expertise ensures that your documentation is precise, compliant, and ready for submission, helping you achieve successful regulatory approval.
Submitted to CDER.
Required after pre-clinical studies but before initiating a clinical trial.
Request for FDA authorization to administer an investigational drug to humans.
Investigator IND: Submitted by Physician.
Emergency IND: to authorize use of an experimental drug in an emergency situation.
Treatment IND: submitted for experimental drugs showing promise in clinical testing for serious or immediate life-threatening.
Submitted for the review and approval of a generic drug.
Termed abbreviated because this submission is generally not required to include pre-clinical and clinical data.
Drug must demonstrate therapeutic equivalence to a previously approved “reference listed drug”.
Drug must demonstrate therapeutic equivalence to a previously approved “reference listed drug”.
Submitted to CBER.
Submitted for vaccines, blood and blood components, somatic cells, gene therapy, and other biological drug products.
Regulatory procedure through which sponsors propose FDA to approve a new pharmaceutical drug.
Must establish the safety and efficacy of the drug in its proposed use.
Manufacturing methods and controls adequately preserves the drug’s strength, quality and purity.
Drug Master File (DMF) is a type of submission made to the Food and Drug Administration (FDA) to provide important information related to facilities, processes or ingredients used for manufacturing, packaging or storing of any human drugs.
| Types | Essential Contents |
|---|---|
| I | Manufacturing site, facilities, operating procedure and personnel |
| II | Drug substance & intermediate, material used and drug product |
| III | Packaging material |
| IV | Excipient , flavor , essence, colorant, & material used in preparation |
| V | FDA accepted reference information |
Submission Identification; Identification of the applications; Signature of the holder or the authorized representative; typewritten name and title of the signer.
Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
A description of the purpose of submission, e.g., update, revised formula, or revised process; Signature of the holder or the authorized representative; typewritten name and title of the signer.
Regulatory Operations Manager,
President,
Senior Manager, Regulatory Affairs,
Regulatory Strategy Lead,
President,
27 Jun, 2025
12 Jun, 2025
05 Jun, 2025
29 May, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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