CMC Technical Authoring Services

Chemistry, Manufacturing and Controls

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.

Our Medical & Technical Writing Services

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.

  • 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

Cloud eCTD viewer and dossier management for electronic publishing and submissions

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.

eCTD Viewer - Dossplorer

Features of Dossplorer™ eCTD Viewer:

  • Automated import of dossiers and sequences
  • SaaS solution
  • Intuitive search functionality
  • Explore holistic views across dossiers worldwide
  • Personalized navigation tree utilizing metadata already present in dossiers
  • Multiple dossier formats supported
  • Advanced restrictions
  • Integrated eCTD viewer with Single Sign-on solutions

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:

Drug Substance

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.

Technical Writing Services in the US FDA Drug Approval Process

Navigating 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.

Preclinical studies

Investigational New Drug (IND) to CDER

Phase I
Phase II
Phase III

New Drug Application (NDA) to CDER

Advisory Committee Meetings

Approval
Phase IV

Celegence Technical Writing Services for US FDA Drug Submissions

Investigational New Drug Application (INDA)

  • 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.

Biological License Application (NDA)

  • Submitted to CBER.

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

Abbreviated New Drug Application (ANDA)

  • 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.

  • Hatch-Waxman Act establishes the basis of approving a generic drug product.

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

New Drug Application
(NDA)

  • 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.

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

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, application of 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.

Industry Leaders Trust Celegence

Celegence - Novartis - Life Science Regulations
Bausch Health - Life Science Regulations
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Your Trusted Partner for Regulatory Affairs Excellence

“We are extremely satisfied with the support and CMC templates provided by Celegence. Thanks to their expertise and the efficiency of the templates, we successfully submitted a business-critical dossier to the EMA with zero major or critical queries – a first for us. This marked a significant improvement compared to past submissions, where major challenges arose without the structured approach Celegence offered. Their collaboration has delivered exceptional results, streamlining our processes, enhancing submission quality, and driving substantial efficiency and cost improvements. We are thrilled with this outcome and look forward to continued success together.”

Dr. Balázs Lázár, Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“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”
Ron Celeste, President, Thinspring

Resources to Assist Your CMC Technical Authoring

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Lean Authoring Checklist

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eCTD v4.0 Overview

Learn about eCTD 4.0 the latest version of the electronic submission standard to submit regulatory applications.

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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