Ennov RIM
Ennov
Ennov provides unified content and information management platforms for the life sciences industry, specializing in regulatory compliance, quality management, and clinical trial support.
Ennov offers a unified platform designed for regulated content and process management within the life sciences sector. Their solutions cover Regulatory (EDMS, Dossier Publishing, RIM, IDMP), Quality (EDMS, QMS), and Clinical (eTMF, CTMS). The Ennov platform is built on a highly configurable software architecture combining business process management, document management, data/form management, learning management, and business intelligence. With over 25 years of experience, Ennov focuses on delivering innovative, powerful, and user-friendly software. Their Regulatory Suite supports the entire product lifecycle, from initial planning to product discontinuation, aiding in regulatory activity planning, product registration management, and dossier creation. Ennov Quality streamlines quality documentation and processes, while Ennov Clinical Suite offers applications for clinical data and trial management. Ennov also provides comprehensive professional services, including implementation, training, and ongoing support, to ensure clients maximize the value of their software investments. Their experienced teams are dedicated to accelerating software implementation and providing continuous support through their dedicated support portal.
About
**Who they are**
Ennov provides unified content and information management platforms for the life sciences industry. With over 20 years of experience, they specialize in regulatory compliance, quality management, and clinical trial support.
**Expertise & scope**
* Offers professional services including implementation, training, and ongoing support for their software solutions.
* Develops optimized project delivery methods to accelerate software implementation and achieve timely, budget-conscious deployment.
* Provides comprehensive training programs designed for users and administrators, available through online meetings or self-paced e-learning.
* Delivers continuous support and maintenance post-implementation, including access to an online knowledge base and support portal.
* Supports a platform that includes Ennov Document, Ennov Workflow, Ennov Data, Ennov Analytics, and Ennov AI.
* Specific regulatory solutions include Doc for Regulatory, Document Transformation, Dossier management (Ennov Publishing, Insight Publishing), Regulatory Information Management (Ennov RIM, Ennov Insight RIM, IDMP), and Artwork management.
**Reputation / proof points**
* Over 20 years of experience in the life sciences industry.
* Hundreds of successful software implementation projects.
* Experience working with companies of all sizes.
Ennov provides unified content and information management platforms for the life sciences industry. With over 20 years of experience, they specialize in regulatory compliance, quality management, and clinical trial support.
**Expertise & scope**
* Offers professional services including implementation, training, and ongoing support for their software solutions.
* Develops optimized project delivery methods to accelerate software implementation and achieve timely, budget-conscious deployment.
* Provides comprehensive training programs designed for users and administrators, available through online meetings or self-paced e-learning.
* Delivers continuous support and maintenance post-implementation, including access to an online knowledge base and support portal.
* Supports a platform that includes Ennov Document, Ennov Workflow, Ennov Data, Ennov Analytics, and Ennov AI.
* Specific regulatory solutions include Doc for Regulatory, Document Transformation, Dossier management (Ennov Publishing, Insight Publishing), Regulatory Information Management (Ennov RIM, Ennov Insight RIM, IDMP), and Artwork management.
**Reputation / proof points**
* Over 20 years of experience in the life sciences industry.
* Hundreds of successful software implementation projects.
* Experience working with companies of all sizes.
Additional information
Ennov's approach to software implementation focuses on delivering tangible results rapidly through a clear, repeatable framework with defined milestones. Their professional services team is experienced in guiding projects from inception, understanding critical questions to ask and avoid. Training is role-based and practical, offered in various formats to suit client needs. Post-implementation, their customer support team ensures continued system operation and optimal use of Ennov software, with access to an online knowledge base and support portal for service requests and updates.
Key Highlights
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Provides specialized regulatory information management solutions, including IDMP support.
Source
“Regulatory Information Management EnnovRIM Ennov Insight RIM IDMP”
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Offers a comprehensive suite of services including implementation, training, and hosting.
Source
“Ennovでは、20年以上にわたってライフサイエンス業界にソフトウェア・ソリューションを提供してきた豊富な経験と、何百もの導入プロジェクトに基づいて、お客様がEnnovソフトウェアから最大限の価値をできるだけ早く引き出せるように、最適なプロジェクト導入方法を開発しました。”
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Experience includes hundreds of successful software implementation projects.
Source
“Ennovのプロフェッショナル・サービス・チームは、何百ものソフトウェア導入を成功させてきた非常に経験豊富なチームです。”
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Training programs are designed for users and administrators, with flexible delivery options.
Source
“Ennovの教育サービスチームは、20年以上にわたり、何千人ものユーザーや管理者が、弊社ソフトウェアの設定や操作に必要な知識を習得するためのサポートを行ってきた実績があります。”
Certifications & Trust Signals
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Over 20 years of experience providing software solutions to the life sciences industry.
Source
“Ennovでは、20年以上にわたってライフサイエンス業界にソフトウェア・ソリューションを提供してきた豊富な経験と、何百もの導入プロジェクトに基づいて、お客様がEnnovソフトウェアから最大限の価値をできるだけ早く引き出せるように、最適なプロジェクト導入方法を開発しました。”
Buyer Snapshot
Best for
- Life sciences companies seeking integrated content and information management.
- Organizations requiring specialized support for regulatory compliance and information management.
How engagement typically works
- Project-based implementation services.
- Structured training programs (online, on-site, e-learning).
- Ongoing customer support and maintenance.
Typical deliverables
- Accelerated software implementation.
- Role-based training sessions.
- Ongoing system support and maintenance.
- Access to knowledge base and support portal.
Good to know
- Best when clients are implementing Ennov's software solutions.
HQ:
Paris, France
Languages:
English, French
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, ES, IE, PL, IT, SE
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Usage-based
Starting from:
EUR 1,200
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Clinical investigations, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Ennov develops optimized project delivery methods for software implementation, aiming for defined milestones and a repeatable delivery framework to build production-ready systems within a relatively short timeframe.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Regulatory Information Management (RIM), Dossier Management, Document Management, Workflow Management, Data Management, Analytics, AI
Supports Actor Registration
Implied through RIM and regulatory support, but not explicitly stated as a standalone service.
Supports UDI
Implied through regulatory support, but not explicitly stated as a standalone service.
Supports Vigilance
Implied through regulatory support, but not explicitly stated as a standalone service.
Supports Clinical Investigations
Implied through regulatory support, but not explicitly stated as a standalone service.
