Essenvia
Revolutionizing FDA 510(k) submissions, this Regulatory Information Management (RIM) platform streamlines regulatory workflows throughout the product lifecycle. With a centralized repository for documentation and collaborative authoring capabilities, it enhances efficiency and accelerates global market access, ultimately driving business growth and ensuring successful product launches.
Top Essenvia Alternatives
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ClinChoice offers a sophisticated Regulatory Information Management (RIM) system designed to streamline the regulatory process for pharmaceuticals and biotech products.
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RIMTrack is an innovative cloud-ready regulatory information management system designed to streamline submissions and regulatory processes for healthcare organizations.
Samarind RMS
Samarind RMS revolutionizes medical product information management by enabling users to input data just once for multiple submissions, such as renewals and variations.
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This cloud-based platform revolutionizes regulatory affairs by digitizing and automating the entire regulatory process.
Kalypso Accel for RIM
Accel for RIM accelerates regulatory information management for life sciences companies, streamlining product registrations and submissions.
ViSU
ViSU is an integrated Regulatory Information and Business Process Management platform that digitizes and automates various business processes.
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DXC RIM
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harmon.ie
By simplifying the classification, storage, and retrieval processes, it enhances compliance and boosts user adoption...
Top Essenvia Features
- Centralized regulatory information repository
- Collaborative authoring for eSTAR submissions
- Executive dashboards for lifecycle view
- Proactive alerts for submissions
- Global registration status tracking
- Integration with ERP/PLM systems
- Extensive compliance templates library
- Reusable content automation
- One-click final submission generation
- Automated regulatory change assessments
- Impact analysis for regulatory changes
- Project management for change assessments
- Simultaneous user collaboration support
- Elimination of technical holds
- RTAs
- and RFIs
- Cross-functional efficiency gains
- Accelerated product launch capabilities
- Customized alerts and notifications
- Peace of mind for compliance
- 100% submission acceptance rate guarantee
- Shortened time to market
