Ennov regulatory suite
Regulatory Information Management Software
- Comprehensive RIM solution
- Intrinsically connected to Ennov Doc and Ennov Dossier
- Fully configurable to support your entire product portfolio
- Workflow driven
- Robust data querying, reporting and visualization
The Regulatory Information Management Challenge
The global regulatory landscape is getting more complex. In the United States, half of the FDA’s NDA approvals come with a commitment to conduct additional clinical trials. In the European Union, the complexity of regional submissions continues to increase. And, while emerging markets represent growth opportunities, the vague submission requirements of local health authorities can make gaining market approval somewhat unpredictable. All of these factors underscore the need for robust Regulatory information management capabilities.
Regulatory information management at global organizations is rarely integrated and usually consists of collections of spreadsheets, homegrown databases, emails and ad hoc reports – each full of redundant and/or inconsistent data.
However, as product registrations become increasingly complex and volumes increase, companies are realizing that the ability to answer business-critical questions about all regulatory activity in an efficient and timely manner is critical to effective operations that ensure enterprise-wide compliance.
Ennov RIM - Your Single Authoritative Source of Regulatory Information
Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests.
Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide.
The 100% web-based solution includes an intuitive and configurable user interface, Regulatory task management, e-mail notification capabilities and correspondence and commitment tracking functions. Ennov RIM’s Regulatory activity planning feature provides the ability to manage submission projects that span many applications – information is entered once and replicated across products, countries and applications as appropriate.
Increase Operational Efficiency
Ennov RIM translates data into action. It is a process-driven solution that clearly identifies what needs to be done, when and by whom. Its robust workflow capabilities ensure visibility into assignments and deadlines through automatic e-mail notifications and real-time status updates. Robust querying and visual dashboard reporting provide complete visibility into the all the activities within your Regulatory operation.
Ennov RIM provides the ability to efficiently manage your entire product portfolio including small molecule therapies, large molecule therapies, medical devices, drug-device combinations, nutritionals/supplements and more. Our comprehensive yet flexible solution will give you confidence that your registrations stay up-to-date and all of your products stay on the market.
Innovative Dashboards to Support both Planning, Impact Analysis and Metrics
Ennov’s RIM dashboards support all of the professionals who use RIM. Regulatory Operations can see the volume of upcoming workload, and instantly understand coming due and overdue activities. Quality professionals can perform impact analysis to see what registrations are affected by a change in manufacturer, active substance or excipient. Management can view information about timeliness and volume of regulatory activities. Out of the box dashboards cover all regulatory activities including submissions, correspondence and commitments and provide specialized analysis for PSURs, impact analysis, and much more.
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning, product registration management, dossier creation, dossier management and more.