AI Reality Check & The IDMP Countdown
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
April 28, 2025
Category: Insider
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
AI Vendor Checklist
Generative AI and LLMs are rapidly becoming essential in life sciences. To maximize impact, companies must critically assess use cases and choose vendors whose tools integrate seamlessly with their teams.
April 11, 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
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 & Medical Devices: What’s Happening in 2025?
Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode,
February 14, 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
Ennov Training
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
February 7, 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 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
Future-Proofing Quality Management: A Guide for SMBs in Life Sciences
For small and mid-sized life sciences companies, maintaining quality standards amid constant industry evolution is an uphill battle. With limited resources and leaner teams, these
May 22, 2024
AI in Quality Management with ION Pharma
In this podcast, Ennov joins ION Pharma to discuss the complexities of modern quality management systems and how AI is becoming an indispensable ally in
April 8, 2024
AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury
In a pioneering collaboration, the leading entity in the luxury cosmetics industry, known for its commitment to innovation and quality since 1987, has partnered with
March 7, 2024
Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
February 7, 2024
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
December 20, 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
PV-Signal Manager
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
May 4, 2023
PV-Works Vet
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
May 3, 2023
PV-Works Human
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
May 2, 2023
PV-Analyzer
Efficiently detect potential signals with Ennov PV-Analyzer. A feature-rich, easy-to-use statistical analysis tool for pharmacovigilance.
May 1, 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
Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.
April 24, 2023
Ennov CTMS
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
April 21, 2023
Ennov Doc for Regulatory
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
April 21, 2023
Ennov EDC
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
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 eTMF
Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.
April 20, 2023
Ennov Process
Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.
April 20, 2023
Going Paperless: Best Practices for Creating Certified Copies
In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an eTMF system.
April 13, 2023
Case Study: Horiba
Horiba leverages a DMS to standardize workflows, eliminate paper, reduce time spent searching for information, and improve collaboration between departments.
March 27, 2023
Case Study: Maincare
Learn how Maincare is leveraging Ennov Doc and the Ennov REST API to include document management capabilities in their products.
March 14, 2023
Ennov RIM
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
March 12, 2023
Case Study: PV Animal Health
Ennov assisted a valued Animal Health customer of almost 20 years in moving PV operations from a local installation to a new SaaS cloud environment.
November 22, 2022
Ennov Serves as Global Patient Call Center Platform
Implementation of the Ennov solution resulted in a responsive call center platform to support global patient interactions.
May 30, 2022
Case Study: IRE
This QMS project had two major objectives: ensure the safety of patients and staff, as well as foolproof reliability.
January 28, 2022
Completeness, Quality and Timeliness: A Deep Dive
This paper will examine the KPIs of Completeness, Quality and Timeliness in more detail in order to assist organizations in improving the quality and understanding of these metrics and their roles in risk management, continuous process improvement, and compliance.
January 25, 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
White Paper: Clinical Analytics: The Journey from Problem Identification to Solution
Risk-based clinical quality may require information from: the CTMS and eTMF, but also from the EDC, ePRO, RTS, RIMS, and QMS.
November 8, 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
MHRA TMF Inspection Finding Checklist
Review tactics for preventing common eTMF Inspection Findings
February 23, 2021
Ennov CTMS Dashboards
Learn how Ennov Analytics Dashboards are used to manage risk, increase efficiency and improve insight.
January 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
Product Demo: Unified CTMS and eTMF
Learn how Ennov CTMS and eTMF enables planning, management, documenting of clinical trials.
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
eDMS and Office 365 Integration
Learn how Ennov Doc’s integration with Office 365 drives innovation through collaborative authoring.
November 30, 2020
White Paper: Unified CTMS and eTMF
Learn the key areas where a unified CTMS and eTMF can result in the greatest benefit.
November 30, 2020
Managing Clinical CAPAs
Learn why effective management of Clinical CAPAs is key to operating in a state of control.
November 30, 2020
Optimize Your TMF Strategy
Learn why an optimized TMF strategy is essential to maintaining inspection readiness and reducing risk.
November 30, 2020
Case Study: Vetoquinol
Learn how Vetoquinol implemented Ennov Doc and Ennov QMS to reduce compliance risk and improve performance.
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: Pure Drug Safety
Utilizing Ennov PV to drive drug safety outsourcing services to pharmaceutical companies.
November 30, 2020
Case Study: Laboratoire Aguettant
Aligning regulatory activities to strengthen competitive position.
November 30, 2020
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