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
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.
Senior Manager, Regulatory Affairs, Fulcrum Therapeutics
“Working with Celegence on our publishing and submission activities has delivered significant value. Their client-focused approach, combined with deep regulatory knowledge and smart tools like Dossplorer, enabled real-time collaboration and faster decision-making. Thanks to their support, we were able to meet tight deadlines without compromising quality—cutting publishing time significantly for major submissions and reducing rework substantially. Celegence’s professionalism, responsiveness, and commitment to our success have made them an essential extension of our internal team. We’re confident that with Celegence, we have the right partner to support our regulatory operations moving forward.
Regulatory Operations Manager, Stallergenes Greer
“We are very satisfied with our collaboration with Celegence. For several years now, we have been relying on them for the XEVMPD submission of our data. On the strength of this positive experience, we have extended their scope of intervention to include data entry in LifeSphere and are now embarking on a new project to enrich our IDMP data in this same solution. Their in-depth expertise and perfect understanding of regulatory requirements, combined with a pragmatic, results-oriented approach, have significantly enhanced the quality and efficiency of our data management processes. What sets Celegence apart is their ability to quickly identify our specific needs and propose tailor-made solutions, which is a key factor in our success. Their structured and proactive support enables us to reach important milestones with serenity and clarity. As we continue to transform our regulatory operations, choosing Celegence as our long-term partner was a natural strategic decision. We look forward to continuing this fruitful collaboration.
Head Global CMC Regulatory Affairs, Kenvue
“I have been working with Celegence for several years and very much appreciate their partnership on so many levels. Celegence has very strong CMC experience and not only provided us much needed consultant services, but they also worked with us to utilize and leverage industry-disrupting digital solutions, Dossplorer™ and CAPTIS®. These tools have changed how we access and use our own data. Dossplorer™ (a dossier viewing tool) was upgraded with industry leading features such as translation, a goggle-like power search, document compare and many others that drastically reduce the time it takes to perform change impact assessments, document comparisons, translation and search within non-English documents and the ability to upload many other critical Health Authority documents keeping our dossiers fully compliant and current. Since Dossplorer could be used by anyone in Kenvue, it gave this power to all our stakeholders and business partners as well. CAPTIS® (an AI enabled technical/medical writing tool) was piloted with the CMC team in Kenvue to see where we could leverage using AI to author Module 3 quality submission ready documents. The Celegence team was able to automate technical writing for 5+ of the most frequently written Module 3 quality submission documents to streamline our life cycle management workload and resources. The documents Celegence provided using their AI tool were shown to be remarkably reliable when compared to manual preparation. This pilot showed the art of possible. We achieved great things with Celegence and appreciate their collaboration and expertise.
Regulatory Strategy Lead, Recursion Pharmaceuticals
“Partnering with Celegence for our publishing and submissions has been a game-changer. Their combination of knowledgeable, client-focused experts and technology-enabled services has dramatically improved our efficiency. The use of Dossplorer’s real-time review and commenting capabilities played a pivotal role in meeting tight submission deadlines. From collaborative document preparation to seamless eCTD publishing, their tools and expertise have directly accelerated our submission and approval timelines. With Celegence’s support, we cut our publishing time in half, minimized rework, and consistently met aggressive timelines. Their responsiveness and commitment to excellence make them one of our most reliable business partners. I would never hesitate to recommend their services."
President, ThinSpring
“Celegence has consistently demonstrated the value of their tech-enabled services in improving efficiency and compliance. The use of eCTD templates saves significant hours of document readiness and rework – streamlining the preparation and reducing publishing timelines. These templates consistently deliver hard returns on investment, helping organizations save time and resources. Additionally, the use of Dossplorer’s real-time review and comments feature was instrumental in meeting submission timelines, which otherwise might not have been achievable. From document collaboration to seamless publishing, Celegence’s tools and expertise are driving measurable time-to-market improvements and enabling success where it matters most. Celegence’s tech-enabled services consistently deliver immediate value. Qdossier supported by eCTD submission experts, allowed us to cut our publishing time for a full New Drug Application in half. Rework was minimized, allowing us to meet aggressive timelines. Customer service responsiveness is top-notch. Celegence is the best business partner we’ve had in our 25 years. We managed to publish a full NDA with a very aggressive timeline; we have successfully submitted it to the FDA just 12 working days after we started publishing the first set of documents. A total of 645 PDF files have been published, 450 dataset files have been included, and almost 2000 hyperlinks have been created in this dossier. The submission itself has been reviewed by the customer directly in Dossplorer, which was a key solution with this challenging timeline.
Head of Data Management, B Braun
25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
25 Apr, 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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