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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Creating well-written and structured documents is crucial for drug approval and submission. Regulatory medical writing involves compiling information from clinical trials, safety reports, and other key documents to produce submission-ready materials for M2, M4, and M5 modules.
Celegence’s global medical writing specialists are experts in drug development, multiple therapeutic areas and product types. We have in-depth knowledge of regulatory, clinical, and scientific content, integrated with technical, editorial, and quality control skills. Our writers collaborate with various stakeholders, including clinical operations, data management, biostatistics, medical, and safety teams. They bring extensive industry experience from pharmaceuticals, medical devices, CROs, service providers, and academia, covering all forms of medical and scientific writing.
CMC Technical Writing Services
Publishing and Submission Services
Integrated planning and execution, coordination of all writing and review activities across various domains and therapeutic areas.
Medical writing, editing, comprehensive review of regulatory and scientific documents, and responses to regulatory and health authorities.
Routine reviews for specific therapeutic and product areas.
Incorporating clinical and scientific results, evaluation reports, literature references, graphics, tables, and data listings.
Reviewing and providing input on medical and scientific data, including gap analyses.
Insight into clinical research, device/drug development processes, regulatory requirements, good clinical, and data management practices.
Manuscripts, posters, presentations, and slide decks for advertising/promotional material.
Timely delivery with a focus on high standards of quality.
Timely delivery with a focus on high standards of quality.
PBRER, PSURs, DSUR, PADER, PAER, SSUR, and country-specific safety reports.
CCDS, RMP, PPI, Package Inserts/Medication Guides, USPI, SmPCs, INDs, NDAs, MAAs, and other international drug submissions, briefing documents for agency meetings.
Lean authoring offers a transformative approach to streamline submissions, reduce redundancy, and improve compliance outcomes. By emphasizing clarity and structured documentation, this method is helping organizations tackle the evolving regulatory challenges for pharmaceuticals, medical devices, and beyond.
Download now to unlock your access to the Lean Authoring Checklist and discover actionable steps to streamline your regulatory submissions.
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Director of Regulatory Services, Pharmaceutical
With 20+ years of Pharmaceutical industry experience across Drug Discovery, Regulatory Affairs, and Compliance, Pradeep is a system and business process owner leading our Pharma division delivery teams. Pradeep holds a Masters degree in Biotechnology from Bangalore University. Established a Regulatory Operations team for Consumer Health business unit Spearheaded several RIM/eDMS and publishing system migrations Successfully managed xEVMPD integration into P&G Healthcare business unit Led business process harmonization and digitization activities for raw materials documentation and its compliance Co-chaired IDMP office.
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Head of Regulatory Affairs
Marloes provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.
Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Awarded DIA Leader of Tomorrow in 2016. Helped author the biosimilar guidelines across the globe.
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Regulatory Affairs SME
Diede is a Regulatory Affairs Subject Matter Expert. She specializes in clinical trial applications and scientific advice, with a primary focus on regulatory processes within Europe, including European Medicines Agency (EMA) and Clinical Trials Information System (CTIS). With experience in Regulatory Intelligence, eCTD template development, and Module 1 documentation support – including electronic Application Forms (eAF), Product Information, and Risk Management Plan (RMP) updates – Diede brings a thorough understanding of regulatory strategies to her role. She holds a PhD in Hemato-pathology and both a Bachelor’s and Master’s degree in Biomedical Sciences. Her academic expertise, combined with her industry experience, enables her to navigate regulatory landscapes and provide guidance to clients.
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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.
Dosscriber™ helps stand-alone regulatory documents for, amongst others, NDA/BLA, IND, NDS, MAA, CTA, PIP, scientific advice, and briefing packages.
With consistent document structure, naming, and eCTD-readiness, Dosscriber™ templates facilitate repurposing documents across countries, products, and dossier types – without rework.
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.
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.”
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.”
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.”
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.”
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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