M4Q Revision 2: Shaping the Future of Quality Submissions
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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Author Right the First Time.
When creating dossiers for new products, different strengths, or various countries, it is common to rework and duplicate documents. Consequently, the content remains identical, but submission-specific values like naming, cross-references, and document headers vary each time.
100% of our first-time submissions have been accepted by health authorities since 2022.
We are prepared to help pharmaceutical companies transition to the new eCTD version
Celegence enables companies to author Right-First-Time (RFT) documents using the full set of Dosscriber™ eCTD document templates (other formats also available, e.g., ASEAN). The document templates optimize lifecycle management, ensure consistency, and avoid duplication of work.
From our extensive experience with pharma clients, we have put great effort into avoiding document duplication. Therefore, we created eCTD templates to ensure accuracy, consistency, and reusability of documents across dossiers.
Dosscriber™ features content control boxes and pick lists to ensure your content complies with regulatory standards.
One of the foundational pillars of our eCTD templates is separating content from context. This concept is key to ensuring document reusability and saving time when creating global dossiers.
Our common technical document templates apply tabular formats or bullet lists for factual information, where possible. Additionally, placeholders are used for factual values, and content control boxes are aligned with IDMP implementation guidelines.
Dosscriber™ supports the automatic creation of TOCs, PDF bookmarks, and cross-references, which results in optimal navigation and significantly reduces the time required to publish to eCTD format.
For each eCTD subsection, our templates offer support for both coarse and fine granularity (single- or multiple documents). This provides flexibility when outlining your submissions.
eCTD templates include document header information and prefilled naming properties, ensuring consistent use of metadata. These are designed to optimize reuse without rework across products, countries, and strengths.
Standardized narratives are included for key eCTD sections, providing the right amount of detail across documents, sections, and dossiers.
Dosscriber™ allows you to create documents that are 99% submission-ready upon completion. Features like bookmarks, hyperlinks, and TOCs are automatically generated by following heading styles, reducing the time required for PDF publishing and speeding up dossier compilation.
Considering that Module 1 of eCTD dossiers is country-specific, we have created Module 1 eCTD templates tailored to each country/region.
Hidden regulatory guidance is provided to help authors, sourced from ICH guidelines, and enriched with insights from recognized experts, including former MHRA assessor and ICH representative Anthony C. Cartwright. Our templates are regularly updated to remain compliant with the latest regulatory standards.
Practical experience is included as hidden text or in separate manuals for CTD modules and subsections (e.g., Module 2, 32P, and 32S). Hands-on training is provided to ensure users are familiar with the Dosscriber™ templates.
Lean authoring offers a transformative approach to streamline submissions, reduce redundancy, and improve compliance outcomes.
Traditional regulatory submissions often involve transferring large narrative documents in PDF format. Health authorities then extract and analyze this information, introducing inefficiencies and potential errors. Lean authoring, combined with structured data approaches, offers a revolutionary alternative:
Instead of transferring static documents, eventually organizations might be able to collaborate with health authorities through secure cloud-based platforms (several initatives are currently steered in this direction). These platforms allow real-time access to lifecycle-managed data, eliminating the need for repetitive submissions.
Structured templates draw directly from databases, ensuring accuracy and consistency while significantly reducing the time required for manual data entry.
Presenting information in tables rather than narrative text reduces linguistic ambiguities, making it easier for reviewers to interpret the data accurately.
Global initiatives like the FDA’s PQCMC and ICH M4Q revisions are already pushing for such database-driven regulatory submissions. These initiatives aim to replace traditional document submissions with streamlined data exchanges, setting a new standard for efficiency in the regulatory space.
Organizations that adopt lean authoring principles can unlock significant benefits across various stages of the regulatory process:
Lean authoring reduces the time required to author, review, and publish regulatory documents by eliminating unnecessary content and streamlining workflows.
By using modular, reusable documents, organizations can minimize inconsistencies and ensure uniformity across submissions.
Streamlined processes translate into lower compliance costs, allowing organizations to allocate resources more effectively.
Shared templates and structured formats facilitate better communication between stakeholders, including regulatory teams, health authorities, and other partners.
Concise and well-organized documentation accelerates the review process, leading to quicker regulatory approvals and market access.
By leveraging eCTD-ready templates and regulatory expertise, Dosscriber™ enables efficient authoring with reduced risk of major or critical queries during submissions.
Incorporating XML-tagged templates, Dosscriber™ ensures that information is organized and readily extractable, aligning with best practices for regulatory compliance.
With Dosscriber™, clients can create modular, standalone documents that are reusable across multiple submissions, reducing redundancy and improving submission efficiency.
Data Management Specialist
Kosta is an experienced IT professional based in the Netherlands, with over 12 years of specialized expertise in managing and implementing IT solutions for the pharmaceutical industry, including business-critical applications, such as RIMS, Submission and Publishing, and DMS.
As Product Owner at Celegence, Kosta oversees the continuous development and validation of innovative proprietary software applications. He is committed to delivering high-value solutions through agile methodologies, ensuring that business requirements are effectively translated into technical solutions.
He holds a Master’s degree in Business/Managerial economics from the University of Zagreb.
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Regulatory Compliance Manager
With an engineering background and four years of experience in life sciences, Koen brings sharp analytical and critical thinking skills to both internal and client projects. He specializes in regulatory submission planning, Regulatory Information Management Systems (RIMS), and the implementation of new tools and processes into existing operations. His expertise spans project planning and management, reference and master data management, computerized system validation, and system implementation—ensuring seamless compliance and operational efficiency.
At Celegence, he leads regulatory initiatives, ensuring high-quality data integrity, process optimization, and seamless collaboration with stakeholders. With a strong background in clinical research and vendor management, he plays a key role in driving compliance and operational efficiency in regulatory services.
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Associate Director of Regulatory Operations and Publishing
Maikel Bouman is our Associate Director of Regulatory Operations and Publishing, with 8 years of industry experience. He has broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation, and dispatch of different types of electronic submission formats to various regulatory authorities across the Americas, Europe and Australia.
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Senior Manager – Publishing & Submission
Dhana Kumar has 18 years of experience in Publishing and Submission. His expertise includes publishing submission for US, EU and other countries. He acts as a Subject matter expert for Document publishing and Regulatory Submission.
He is trained in publishing software, such as Docubridge and eCTD Manager and has good experience in Adobe and TRS Toolbox and working on Automation for eQC.
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16 Dec, 2025
13 Nov, 2025
11 Nov, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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