ENNOV
Regulatory Information Management Expert
Comprehensive Regulatory Compliance and Quality Management Solutions
ENNOV is an expert in life science regulatory information management with over 25 years of experience, serving 450+ life science clients worldwide with 500,000+ users. The company provides a complete suite of regulatory compliance and quality management solutions, encompassing electronic submissions (eCTD), quality management systems (QMS), and enterprise document management systems (EDMS), built on a unified single-database architecture that ensures seamless integration across all modules.
ENNOV is a native AI pioneer in the GxP platform space, being the first to integrate artificial intelligence into regulatory compliance platforms. All products comply with 21 CFR Part 11 and EU Annex 11 regulatory requirements and have been validated by global regulatory agencies including FDA and EMA.
ENNOV Solutions
A complete regulatory information management platform to meet your compliance needs
eCTD247
Cloud-based SaaS eCTD submission authoring platform with 11 successful eCTD 4.0 pilot submissions, supporting all application types including IND/NDA/ANDA/BLA/MAA, with a built-in EMA-certified validation engine.
Learn MoreEnnov Quality Suite
Integrated electronic quality management system covering document management, quality events, training management, and analytics. Unified single-database architecture, aligned with the DIA EDM Reference Model, with native AI capabilities.
Learn MoreEnnov Doc
Enterprise Document Management System (EDMS) designed for regulated industries. Compliant with 21 CFR Part 11, trusted by 450+ life science clients with 500,000+ global users, supporting IDMP data governance.
Learn MoreWhy Choose ENNOV?
Life Science Clients
Over 450 life science clients worldwide trust ENNOV, spanning pharmaceutical, biotech, medical device, and other industries
Unified Single-Database Architecture
All modules share a single database, ensuring data consistency and seamless integration across modules
Global Regulatory Compliance
Compliant with 21 CFR Part 11 and EU Annex 11, supporting requirements from global regulatory agencies including FDA, EMA, PMDA, and TGA
Native AI Pioneer
First to integrate AI in the GxP platform space, delivering intelligent regulatory compliance and quality management capabilities
Supported Regulatory Standards
| Regulatory Agency | Supported Standards |
|---|---|
| FDA (USA) | eCTD v4.0, 21 CFR Part 11, FDA ESG |
| EMA (EU) | eCTD EU Module 1, EU Annex 11, CESP, IDMP |
| PMDA (Japan) | eCTD JP Module 1, JP Gateway |
| TFDA (Taiwan) | eCTD TW format, electronic submission standards |
| Quality Standards | ISO 9001, ISO 13485, GMP, GxP, ICH Guidelines, DIA EDM Reference Model |
| Others | ICH eCTD, Health Canada, TGA (Australia), Swissmedic, etc. |
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