With specialized expertise and a deep understanding of both technical and medical writing, Celegence Pharmaceutical teams provide comprehensive regulatory writing services that support drug development programs from early-stage INDs to NDAs, MAAs, and beyond. Our team excels in creating precise, compliant, and high-quality documents that meet the stringent requirements of regulatory authorities.
We offer end-to-end support from technical writing for CMC documentation to medical writing for clinical study reports and safety summaries. We have extensive industry experience and collaborative approach to ensure that submission documents are delivered on time and to the highest standards, helping clients achieve successful regulatory outcomes.
CMC Technical Writing Services
Medical Writing Services
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Drug Master File (DMF) (M1, M2, M3)
CMC Writing (M2, M3)
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Clinical Writing (M2, M5)
Non-Clinical Writing (M2, M4)
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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.
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.
Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“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.
Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“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.
25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
25 Apr, 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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