The EMA is moving to a phased implementation, requiring MAHs to iteratively enrich data in the Product Management Service. With each stage demanding more information, early preparation is key. Without it, manual processes may become unsustainable. All MAHs face upcoming deadlines—act now to ensure your data, tools, and teams are ready.
Optimizing Artwork Management in Regulatory Processes Join us for a 30-minute webinar on improving Artwork management through standardized, compliant processes. Learn how to better
The increased volume of health authority interactions in the review and approval cycle has created a commensurate challenge for life sciences companies: increased workload and
eCTD 4.0 is one of the main focal points of the regulatory world, and participating in an eCTD 4.0 pilot is a great opportunity to get experience with the future of regulatory submissions. Make sure you’re prepared and get the most out of your pilot experience!
Meeting the EMA’s IDMP requirements is critical, but it doesn’t have to be complicated. Ennov’s powerful automated solution simplifies PMS data enrichment, saving you time
Discover essential strategies in this informative session with Ennov’s own Pierre Stanislawski and Maxime Delpire, as they dive into the challenges of aligning RIM and
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
One of the world’s largest and most respected biopharma companies selected Ennov for its world-class Regulatory Information Management (RIM) system. This leader in animal health
A dynamic, all-in-one regulatory information management solution crafted for medical devices, pharmaceuticals, and combination products. The platform ensures continuous compliance, supports operational agility, and minimizes
Medical device companies must navigate the complexities of new regulations like the EU’s MDR/IVDR and the FDA’s UDI requirements. These mandates demand a higher degree of traceability, transparency, and
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
How are you going to be ready for IDMP compliance? Ennov has the answer.
Maximize your regulatory team’s potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
Why should you consider a Regulatory Platform instead of a standalone RIM solution? In less than 30 minutes, learn first steps, realistic objectives, and business benefits.
Explore concretes examples of divergence between a RIM data model and HA guidance data format.
Learn about enterprise-level data architecture using master level data management.
Discover the best practices for RIM Data modeling in the context of IDMP.
Interoperable structured data is increasingly burdensome for pharmaceutical companies. This white paper examines some real examples of interoperable structured data and provides some recommendations to prepare for future changes.
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
Ennov’s Partnership with Pharma IT provides a full pharma-focused solution that responds with a single repository platform.
Bachem Americas Inc. needed to identify a partner with a flexible
solution that could meet their specific needs for a RIM solution.
Learn how Ennov Analytics frees you from data gathering and spreadsheet manipulation by providing targeted dashboards where you can complete a precise analysis with just a few clicks.
Learn how to decrease the time required to implement Regulatory Information Management systems using a streamlined approach.
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
Learn how Ennov RIM enables the effective management of CMC variation change controls.
Learn how Ennov RIM enables the management and submission of XEVMPD information to the EMA.
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
Aligning regulatory activities to strengthen competitive position.
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