AI and Its Impact on Life Sciences
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
April 22, 2025
Category: Regulatory
IDMP Starter Pack
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.
April 10, 2025
Artwork Management Made Easy (w. practical examples)
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
March 28, 2025
How to Save Time Managing Agency Correspondence with AI
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
March 7, 2025
eCTD 4.0 Pilot Readiness Checklist
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!
February 12, 2025
Effortless Data Enrichment for IDMP Compliance
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
December 13, 2024
Aligning RIM and PMS: Challenges for a Systematic Comparison
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
November 1, 2024
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
October 28, 2024
Transforming Regulatory Affairs for a Biopharma Leader
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
July 12, 2024
Ennov RIM for Med Device
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
June 27, 2024
Compliance Without Compromise: Med Device Edition
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
May 14, 2024
Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
February 7, 2024
IDMP without Data Re-entry
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
November 14, 2023
IDMP: What’s Different This Time?
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
October 27, 2023
Navigating The Regulatory Landscape: The Ultimate Guide to Your IDMP Journey
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
September 25, 2023
Ennov’s Agnostic Solution for IDMP, the EASI connector
How are you going to be ready for IDMP compliance? Ennov has the answer.
July 18, 2023
Why SMBs should choose a right-sized RIM
Maximize your regulatory team’s potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
April 24, 2023
Ennov Dossier
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
April 24, 2023
Ennov Doc for Regulatory
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
April 21, 2023
Best Practices: Master Data Management
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
April 21, 2023
Ennov RIM
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
March 12, 2023
Benefits of Implementing an End-to-end RIM Platform
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.
January 9, 2023
Leveraging RIM for DADI and IDMP | Ep 3: Examples of Divergence
Explore concretes examples of divergence between a RIM data model and HA guidance data format.
June 23, 2022
Leveraging RIM for DADI and IDMP | Ep 2: Enterprise-Level Data Architecture
Learn about enterprise-level data architecture using master level data management.
June 23, 2022
Leveraging RIM for DADI and IDMP | Ep 1: Best Practices for Data Modeling
Discover the best practices for RIM Data modeling in the context of IDMP.
June 20, 2022
IDMP Considerations in 2022: Interoperable Structured Data Reporting
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.
April 22, 2022
Maintaining Compliance: Adapting to Changing Requirements
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
November 26, 2021
Case Study: Pharma IT
Ennov’s Partnership with Pharma IT provides a full pharma-focused solution that responds with a single repository platform.
October 28, 2021
Case Study: Bachem
Bachem Americas Inc. needed to identify a partner with a flexible
solution that could meet their specific needs for a RIM solution.
October 8, 2021
Visualize Your Regulatory Risk and Status with Ennov Analytics
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.
April 26, 2021
Accelerate Time to Value by Leveraging Predefined Regulatory Processes
Learn how to decrease the time required to implement Regulatory Information Management systems using a streamlined approach.
April 26, 2021
Integrating Documentum and Ennov RIM
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
January 19, 2021
Unified PV and RIM
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
January 19, 2021
Unified QMS and RIM
Learn how Ennov RIM enables the effective management of CMC variation change controls.
November 30, 2020
Unified RIM and xEVMPD
Learn how Ennov RIM enables the management and submission of XEVMPD information to the EMA.
November 30, 2020
eDMS and IDMP
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
November 30, 2020
Case Study: Septodont
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
November 30, 2020
Case Study: Laboratoire Aguettant
Aligning regulatory activities to strengthen competitive position.
November 30, 2020
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