CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
ECTD Publishing (Global) for Global Healthcare Company
Project Summary
Celegence is supporting multiple small and mid-sized clients in terms of projects related to formatting, medical writing, publishing and submission as per eCTD and non-eCTD standards for US, EU and APAC regions.
Celegence Solution & Approach:
These activities include:
Highlights:
Protocol formatting as per the agreed template and review protocol document to ensure essential protocol components are included as per applicable guidelines. We are using the applicable style guide for the protocol document.
Performing Investigational Brochure (IB) and Investigational Medicinal Product Dossier (IMPD) formatting as per the agreed template
Clinical Study Report (CSR) formatting and submission of Investigational New Drug application for Phase 1 and Phase 2
Formatting of draft protocol and briefing document / questions, publishing and submission of these dossiers in eCTD format
Formatting of documents related to request for breakthrough status
Pre-Clinical submission documents as per ICH and US FDA guidelines in eCTD format
Conversion from non-CTD to CTD and perform eCTD publishing and submission for market expansion of existing products
Project Achievements
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25 Mar, 2025
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