Beyond Silos: Unifying Quality & Regulatory
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m
June 23, 2025
Category: Regulatory
From Siloes to Synergy: Aligning Quality & Regulatory Ops
Learn how unified platforms eliminate traditional system boundaries to accelerate compliance, reduce costs, and create competitive advantage.
June 23, 2025
EMA IDMP Roadmap: PMS Data Alignment (Session 2 of 2)
As the EMA continues to refine its IDMP implementation approach — including adjustments to PMS migration rules — organizations must shift from a one-time data
June 20, 2025
Ennov IDMP EASI Connector for RIM Integration
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
June 12, 2025
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.
June 3, 2025
EMA IDMP Roadmap: Updates, Requirements and Impact on Industry (Session 1 of 2)
By the end of 2024, EMA released updated IDMP guidance and the PMS implementation guide, following key milestones including the go-live of PMS. Closely connected
May 23, 2025
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 (with practical examples)
This 30-minute webinar covers improving Artwork management through standardized, compliant processes. Learn how to better organize and control your Artwork content while ensuring efficiency and
March 20, 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 accelerated timelines to respond to agency questions and
February 25, 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
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 Artwork
Ennov Artwork offers a powerful set of tools focused on content management, allowing content to be itemized, annotated, proofed, and compared down to the pixel.
May 27, 2024
Ennov RIM for Med Device
A tailored, agile, and comprehensive regulatory information management solution designed specifically for medical devices, enabling seamless global compliance, enhancing operational agility, and reducing the risk
May 27, 2024
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
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
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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