Comprehensive regulatory information management software
Consolidate all your regulatory information. Comprehensive resource for products, registrations, documents, dossiers and activities. Natively integrated with other Ennov regulatory solutions.
Life Science companies streamline regulatory processes, improve data quality, quickly answer to business needs and regulatory authority requests.
The RIM challenge
Selling pharmaceutical products globally implies complying with growing regulatory requirements from numerous authorities. Compliance costs, delays and risks quickly grow without a systematic RIM approach.
Multiple data-sources, inconsistent naming and data entry, changing business needs result in increased time to market and compliance risks. Global recording and tracking of regulatory submissions is critical.
Ennov has over a decade of submission management experience. Our Regulatory Information Management and product registration software allows you to schedule and manage all your submissions worldwide.
Benefits of RIM solution
- Facilitate work – Easy management of submission documents, dossiers and product registration information.
- Ensure compliance – Provide reliable and folly compliant data.
- Be agile – Impacts of product evolutions and regulatory changes becomes easy to handle.
- Be coherent globally – Ensure coherence across business units and countries.
- Natively integrated solution – Avoid integration costs and complexities.
- Time to market – Quickly integrate evolving business needs and solve compliance issues.
A single source of truth for critical data
Implement a global approach to regulatory information: Ennov RIM consolidates scattered activities in a unique repository for products, registrations, documents, dossiers and activities compliant with IDMP.
Our flexible data model can be adadapted to your company’s specificities, organization and the evolving regulatory landscape. Product information is easily understandable and fully compliant with industry requirements.
Increased operational efficiency
Ennov RIM’s unequaled user-friendliness allows every employee to quickly access and understand all needed regulatory information. Collaboration across the business is greatly improved through efficient searching capabilities and easy access to the overall process.
Drilling down into data interactively enables users to easily focus on specific details instead of having to dig through huge reports. Enhanced coordination across services, outsourcing partners, headquarters and affiliates results in tremendous time savings and productivity gains.
Secured market opportunities
Ennov RIM is process-driven solution: you clearly identify what needs to be done, how and by whom. Complete workflow capabilities ensure deadline monitoring. Notifications are automatically sent on time to the task owner. Workflows are highly configurable so as to exactly suit your internal processes.
In addition, realtime dashboards and on-demand reporting provide thorough regulatory intelligence to optimize market authorizations.
- All in one place: documents, processes, data
- Action-oriented: processes unfold the way they should
- Flexible and agile: configurable workflows, data and activities
- User-friendly: easily searchable and scalable
- Product identification (IDMP support and flexible data model)
- Registration management
- HA interactions, commitments and correspondence management
- Submission planning and tracking
- Real-time reporting and visibility
- Document, dossier and archive management
- Regulatory intelligence
Cloud-based or On Site
Ennov RIM in our comprehensive regulatory compliance solution.
Regulatory document management, DIA EDM reference model
eCTD, NeeS, vNeeS, CTD submission dossier management
IDMP compliant product catalog
Comprehensive regulatory information management solution
Why Choose Ennov ?
Pro-active approach to regulatory information
- Facilitate product registration in multiple countries
- By product / product family / product type / substance
- Track all activities with target date / deadline
- By product type / country
- Document versions used in different submissions
- Planification and decision-making assistance
- Identify gaps in submissions
- Change impact analysis
- Use of human resources : time spent on various steps
- Compare activities over similar products / time period
We respect your freedom of choice
- Available as cloud or on premise. You can switch between options at any time.
- If cloud based we offer single-tenancy to minimize version upgrade risks and validation upgrades. Data are hosted locally for total flexibility, improved security and optimized performance.
Structuring AND intuitive
… to registration …