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.
DosscriberTM 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,
President,
Senior Manager, Regulatory Affairs,
Regulatory Strategy Lead,
President,
27 Jun, 2025
12 Jun, 2025
05 Jun, 2025
29 May, 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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