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Certara RIM
Shares tags: verticals, life sciences, regulatory submissions
AI Tool
Elevate Your Regulatory Submissions with Lorenz docuBridge
Seamless eCTD Management for Life Sciences Professionals
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VerticalsLife SciencesRegulatory Submissions
1Effortlessly migrate to eCTD v4.0 with automated conversion.
2Maintain compliance with enhanced audit trails tailored for inspections.
3Optimize global submissions with smart data packaging and structure.
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overview
About Lorenz docuBridge
Lorenz docuBridge is a powerful eCTD management software designed specifically for regulatory affairs teams in the life sciences sector. Its scalable architecture enables teams to effectively handle regulatory submissions in multiple formats and across various regions.
- 1Support for eCTD, NeeS, HTML, PDF, and paper submissions.
- 2Enhance team collaboration with cloud or on-site deployment options.
- 3Streamline complex global regulatory processes.
features
Key Features
Lorenz docuBridge provides advanced tools to simplify your eCTD submissions and enhance compliance. Take advantage of features designed for smooth workflows and effective management of regulatory documents.
- 1Cross-team collaboration with multi-user editing and conflict avoidance.
- 2Automated version detection for effortless updates.
- 3Advanced audit trail visualizations for regulatory inspections.
use cases
Who Can Benefit?
Lorenz docuBridge is tailored for regulatory affairs teams within pharmaceutical and biotechnology companies. It empowers professionals managing submissions and compliance across diverse regulatory environments.
- 1Pharmaceutical companies handling multiple simultaneous submissions.
- 2Biotech firms requiring collaboration from distributed teams.
- 3Regulatory professionals needing robust audit functionality.
workflow
Streamlined Workflow
With docuBridge, your submission processes are simplified through intuitive interfaces and automation. Benefit from features that reduce manual effort and increase accuracy in document management.
- 1Customizable submission packages for supplemental data management.
- 2Integrated workflows with third-party systems for seamless operations.
- 3WebAccess improvements for distraction-free document review.
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Frequently Asked Questions
+What is eCTD and why is it important?
The electronic Common Technical Document (eCTD) is an international standard for submitting applications to regulatory authorities. It is important for ensuring compliance and organizing submission documents efficiently.
+Can I migrate from eCTD v3.2 to v4.0 using docuBridge?
Yes, Lorenz docuBridge supports seamless migration from eCTD v3.2 to v4.0 with automated conversion tools designed to simplify the transition.
+Is Lorenz docuBridge suitable for small teams?
Absolutely! Lorenz docuBridge is scalable to meet the needs of both small teams and large organizations, making it an ideal solution for companies of all sizes in the life sciences sector.