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Creating robust CMC (Chemistry, Manufacturing, and Controls) documentation today requires not only domain expertise, but also agility, scalability, and alignment with evolving regulatory expectations. With generative AI, automation, and expert-led workflows, Celegence offers a next-generation CMC technical writing service to accelerate your timelines and elevate document quality.

At Celegence, we combine deep regulatory and scientific know-how with AI-assisted tools to deliver precise, consistent, and submission-ready CMC dossiers. From early development through post-approval, we help clients transform their CMC authoring practices. 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.

Our technical writing specialists work as an extension of your regulatory affairs team, utilizing AI-enhanced document management and analytics to:

  • Achieve up to 30% improvement in lifecycle management efficiency
  • Consolidate regulatory operations across divisions for standardization and productivity
  • Enable strategic outsourcing of routine maintenance for sustained efficiency
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Industry Leaders Trust Celegence

Our Medical & Technical Writing Services

Celegence supports pharmaceutical manufacturers with the full scope of AI-enabled medical and technical writing services.

Our expertise spans small molecules, generics, biologics, biosimilars, ATMPs, and vaccines. With a blend of regulatory expertise and AI-assisted automation, our CMC Technical Authoring services deliver comprehensive, accurate, and compliant documentation that aligns with evolving regulatory requirements.

Medical Writing Services

Medical Writing Services

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Publishing and Submission Services

Publishing and Submission Services

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M2, M4, and M5 documents nonclinical and clinical overviews, summaries, study reports, integrated summaries

Literature review – AI-powered search & screening accelerates evidence gathering

SmPC, Pack Inserts, Product Rationale, PDR – fast, accurate authoring with automated consistency checks

Dossier writing & updates (CTD/eCTD) – standardized templates and AI-assisted drafting for efficiency

CMC Authoring for MAA, NDA, IND and BLA, IMPD – structured, compliant documentation supported by automation

Labeling and related updates – PIL, CCDS -faster turnaround with AI-supported change tracking

Translation services with proof reading – with AI-assisted translation plus human proofreading for accuracy

RPM, PSUR, DSUR Authoring – streamlined regulatory safety documents using automated data extraction

Technology Empowered

CAPTIS® AI and Automation Technology

In-house AI-powered regulatory compliance technology, designed to streamline medical writing and documentation processes. CAPTIS® AI platform reduces manual effort, enhances regulatory accuracy, and creates effortless experiences for Celegence project teams and our customers.

eCTD viewer and dossier management

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 with highest level of data protection.

eCTD-Ready Templates

Intuitive MS Word templates for eCTD-ready documents without software installation include stand-alone regulatory documents for, amongst others, NDA/BLA, IND, NDS, MAA, CTA, PIP, scientific advice, and briefing packages.

Celegence in-house technology for pharmaceutical support

  • 50%

    Faster delivery with intact quality

  • >95%

    Improved accuracy over manual processes

  • 30%

    In saving against current operational cost

CAPTIS® in Action – AI-Driven CMC Draft Generation

In collaboration with Kenvue, CAPTIS® extracted key data from technical documents to automatically generate a structured first draft of CMC sections – helping teams move from a blank page to a ready foundation in minutes.

About Chemistry, Manufacturing, and Controls (CMC) Technical Authoring

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.

Key Components of the CMC Section include

Collaborative Team

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.

Drug Product Composition

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.

Manufacturing Process

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.

Control of Critical Steps and Intermidiates

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

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.

Analytical Procedures

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.

Stability Studies

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.

Technical Writing Services in the US FDA Drug Approval Process

Navigating the FDA drug approval process can be complex and demanding.

At Celegence, our AI-enabled CMC Technical Writing services support you from pre-clinical through Phase IV, delivering precise, compliant, and submission-ready documentation. By combining regulatory expertise with AI-driven consistency checks and automation, we help you streamline authoring and accelerate approval timelines.

Technical Writing Services in the US FDA Drug Approval Process

End-To-End Publishing & Submission Services

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    Investigational New Drug Application (INDA)

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    Submitted to CDER.

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    Required after pre-clinical studies but before initiating a clinical trial.

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    Request for FDA authorization to administer an investigational drug to humans.

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    Investigator IND: Submitted by Physician.

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    Emergency IND: to authorize use of an experimental drug in an emergency situation.

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    Treatment IND: submitted for experimental drugs showing promise in clinical testing for serious or immediate life-threatening.

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    Abbreviated New Drug Application (ANDA)

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    Submitted for the review and approval of a generic drug.

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    Termed abbreviated because this submission is generally not required to include pre-clinical and clinical data.

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    Drug must demonstrate therapeutic equivalence to a previously approved “reference listed drug”.

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    Drug must demonstrate therapeutic equivalence to a previously approved “reference listed drug”.

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    Biological License Application (NDA)

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    Submitted to CBER.

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    Submitted for vaccines, blood and blood components, somatic cells, gene therapy, and other biological drug products.

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    New Drug Application (NDA)

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    Regulatory procedure through which sponsors propose FDA to approve a new pharmaceutical drug.

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    Must establish the safety and efficacy of the drug in its proposed use.

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    Manufacturing methods and controls adequately preserves the drug’s strength, quality and purity.

Key Differences for Biological License Application from New Drug Applications (NDAs)

While similar in many ways to NDAs for small-molecule drugs, BLAs have some key differences:

  • Depending on the product type, BLAs are submitted to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). NDAs go to CDER.
  • Manufacturing processes and controls are especially critical for biologics, as small changes can significantly impact the final product. The concept that “the product is the process” is fundamental for biologics.
  • Characterization of the final product is often more complex for biologics compared to small molecule drugs.
  • BLAs might require more extensive immunogenicity and comparability studies.

Drug Master File

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.

  • Legal basis: 21 CFR 314.420.
  • DMFs are generally filed to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), any other DMF, or an application for export.
  • The submission of a DMF is not required by law or FDA regulation, and a DMF is submitted solely at the discretion of the holder (entity who owns a DMF).
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

A. Transmittal Letters

A.1. Original Submissions:

Submission Identification; Identification of the applications; Signature of the holder or the authorized representative; typewritten name and title of the signer.

A. 2. Amendments:

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.

From first draft to submission-ready dossiers and lifecycle support, Celegence is your trusted partner in regulatory CMC excellence. Reach out to us to discover how AI-enabled CMC authoring can streamline your regulatory journey.

Your Trusted Partner for Regulatory Affairs Excellence

Caroline Mandret

Regulatory Operations Manager

"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."

Ron Celeste

President

"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."

Ben Dowd

Senior Manager, Regulatory Affairs

"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."

Bimpe Shitta-Bey

Regulatory Strategy Lead

"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."

Contact Us Today

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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