Ennov Regulatory Suite
Having an unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets.
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.
- A single authoritative source: Manage and track all Regulatory documentation, dossiers and data within a single application to streamline operations and increase efficiency.
- Improved performance: Eliminate manual, paper-based processes and record keeping. Automate repetitive and error-prone tasks to achieve productivity gains.
- Global connectivity: Foster collaboration across organizational and geographic boundaries with a common harmonized solution that features an intuitive user interface with local language capabilities.
- Increased visibility: Gain valuable insights into business operations to identify and prevent problematic trends before they lead to quality issues.
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
Management of Administrative, Non-Clinical, Clinical and CMC documentation becomes effective and efficient with Ennov Doc
The fragmented processes for creating, organizing and sharing documents to support your Regulatory submissions can be painful. Reliance on file shares with complex and inconsistent filing schemes, emails and tracking spreadsheets to manage your company’s most valuable assets is inefficient, error prone and risky. Ennov’s fully integrated document management and dossier publishing solution streamlines your Regulatory operations, ensures compliance and reduces your time to market. Our comprehensive functionality combined with outstanding user ergonomics result in very high adoption rates – accelerating your return on investment.
Accelerate approvals with our intuitive and compliant Submission Publishing software
Ennov Dossier supports the creation of both electronic (eCTD, NeeS, VNeeS, eCopy) and paper regulatory submissions through a single, common user interface. Ennov Dossier is 100% web-based, making it the ideal solution for multi-site or global deployments. It has easy-to-use submission assembly tools with controls designed specifically for the capture and management of eCTD metadata. Publishers can drag and drop documents stored in Ennov Doc or any WebDav repository quickly and easily into the submission assembly. Submission assembly templates are provided for the regions that accept eCTD submissions and can be modified to meet your specific needs. Ennov Dossier is a comprehensive and scalable submission publishing solution that is suitable for operations of all sizes and produces output that is complaint with all current regulatory agency requirements.
Gain control of product details, registrations, submissions and regulatory activities with our robust Regulatory Information Management software
Regulatory information management at global organizations is rarely integrated and usually consists of collections of spreadsheets, home grown 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 questions about all regulatory activity in an efficient and timely manner is critical to effective operations that ensure enterprise-wide compliance. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of medicinal product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides users with the key information and functionality to effectively manage your product portfolios worldwide.
Prepare your organization for the emerging ISO standards with Ennov IDMP
The ISO Identification of Medicinal Products (IDMP) standards are a set of common, global standards for data elements, formats, and terminology to identify and exchange information about medicinal products. The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole. Ennov IDMP is a quality controlled solution for data management in support of the new IDMP standard.
Understand the principles of RIM and the expected benefits in 30 mins.
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