Preparing for a Regulatory Inspection
This document provides a comprehensive overview of how to prepare for regulatory inspections conducted by agencies such as the EMA, MHRA, and FDA.
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Streamline Regulatory Publishing with eCTD for faster, more cost-effective regulatory submissions
Simplified eCTD publishing. Effortless compliance. Accelerated approvals.
TransPerfect Life Sciences’ report and eCTD submission publishing is an all-encompassing solution for life sciences companies to efficiently manage and submit regulatory documents in the standardized eCTD format. It helps Regulatory Affairs Departments reduce complexity in the creation, medical writing, document preparation, translation, QC, publishing, and submission of electronic Common Technical Documents (eCTD). Our service integrates automation, organization, and quality control tools to improve efficiency in the submission process.
Streamline your eCTD with comprehensive authoring, translation, and submission publishing service
Quality Control
Ensure the accuracy and completeness of submissions documents through rigorous, automated, 68-step conformity check and QC that is compliant with regional and country-based submission requirements, and best practice.
Document Preparation
Format documents as per regulatory guidelines in compliance with ICH CDISC, FDA, EMA, MHRA, PMDA, MFDS, NMPA, and other agencies. Leverage our built-in translation services for applications in new markets.
Review Aids
Add links, bookmarks and cross-references for easy navigation and review by agencies, including cross document links from summaries to clinical study reports, patient and visit bookmarks for CRFs.
Backbone Generation
Generate the eCTD Module 1 and Module 2-5 XML backbone for required sequences, as well as submission maintenance and application lifecycle management over time.
Medical Writing
Leverage our team of medical writing experts for scientific review, creation of CSRs, Protocols, ICFs, Plans, and many other critical submission documents.
Better ROI
Take advantage of our comprehensive Functional Service Provider (FSP) services for medical writing, translation, formatting, and submission publishing to improve your ROI and turnaround times for submission.
Why Choose eCTD?
Reduce the risk of a technical Refuse to File (RTF) with services that simplify the eCTD creation, lifecycle management, and submission.
It eliminates the need for several vendors by using comprehensive services while accelerating approvals with real-time user collaboration.
It streamlines the submission process with a centralized approach while maintaining high standards throughout with rigorous QC and preparation process within deadlines.
Handle multilingual content submission with ease and 100% regulatory compliance with our translation services and expertise in formatting in accordance with region or country standards.
Prepare eCTD submission-ready clinical study reports that are compliant with region or country standards.
Ensure quicker approvals with automated processes, reduce training costs and improve operational workflows for better overall performance.
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