eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in…
2025 in Review: AI, further simplifying compliance with our unified GxP platform, and many more
In 2025, Ennov did what we've always done best: worked closely with the life sciences industry to deliver a unified compliance platform that keeps pace with regulatory change, operational complexity, and growing…
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 and ensuring accuracy. Why It…
How Rhenus Logistics Unified Quality Operations Across Borders
Rhenus Logistics’ paper-based quality processes were slowing approvals, complicating audits, and creating compliance risk across its sites. By adopting Ennov’s validated Quality Management platform, Rhenus standardized documentation, aligned workflows across…
IDMP Standalone Agnostic Approach: Challenges and Achievements
Developing generic IDMP capabilities independently from the RIM system has gained increasing interest, similar to how eCTD publishing is handled separately from eDMS. The expected benefits of this approach include…
Perspectives from Paris: What’s on the Horizon for 2026
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. If this is your first time tuning in,…
Introducing Ennov 11.0: AI-Powered Productivity for Regulated Teams
A smarter, faster, unified way to work across Regulatory, Quality, Clinical, and Pharmacovigilance, now with powerful, built-in AI. Ennov 11.0 is here, and it’s our most advanced release yet. It…
Ennov IDMP EASI
Learn how IDMP EASI accelerates PMS alignment, automates data preparation, and ensures IDMP-ready quality at scale.
Fireside Chat: Navigating Regulatory Challenges for CLIA Labs & IVD Startups
In this fireside chat, Hal Mann and Dave Petrich, MBA, RAC discuss the evolving regulatory landscape facing CLIA labs and IVD startups, sharing practical guidance on maintaining data integrity, streamlining…
When Academic Excellence Meets Regulatory Reality: A 13-Year Success Story
For over 13 years, Cardiff University’s Centre for Trials Research has relied on Ennov’s EDC platform to power more than 100 cancer studies, delivering regulatory-grade quality on academic budgets. Built…
eCTD 4.0: What’s Changing and How to Be Ready
The transition to eCTD 4.0 is underway, and as many publishers have already discovered, it’s not just a minor update. During a recent customer session, I shared what’s really changing,…
How HTL Biotechnology Saved 3,500+ Hours Annually by Digitalizing Quality
When manual approval processes began to slow expansion, HTL Biotechnology partnered with Ennov to digitalize quality management and eliminate paper-based bottlenecks. Through Ennov’s unified Quality Suite, HTL transformed document control,…
How Delpharm Standardized Quality Across 16 Sites
Delpharm’s acquisition strategy created complexity across 16 global sites, each operating under different systems and standards. Ennov’s Quality solution changed that. Through centralized governance, standardized training, and complete digitalization, Delpharm…
Ennov Partners with Matador to Bring Unified Life Sciences Solutions to Japan
Ennov is pleased to announce a strategic partnership with Matador, a leading software distributor dedicated to bringing international life sciences solutions to the Japanese market. This collaboration strengthens our ability…
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.
PMS: Mind the (Data) Gap
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 joined by Michiel Stam, management…
What Is RIM in Life Sciences?
RIM stands for Regulatory Information Management, a simple acronym for a complex task! RIM data spans many domains in life sciences but can be broadly defined in two categories: information…
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data into the e-Application Form (eAF). …
Combo Products, Complex Rules: Regulatory Strategies for Combination Products
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 joined by Plamena Entcheva-Dimitrov, PhD,…
Medical Devices Aren’t Drugs (And Your RIM Shouldn’t Treat Them Like They Are)
Why Medtech teams need systems that reflect their reality, not pharma's When health authority regulatory systems were first designed, they catered to pharmaceutical regulations. Data models supported drug products; workflows…
Combination Products: Global Regulatory Strategy Essentials
We recently sat down with Plamena Entcheva-Dimitrov, PhD, RAC, founder of Preferred Regulatory Consulting, to discuss combination products. Below are the key takeaways from our conversation or you can listen…
Veterinary Pharmacovigilance (PV) Client Success Advocate – USA
As a key member of the Customer Support team, the mission of the Customer Support Engineer is to answer customer requests and issues regarding to the usage of Ennov Software, from a functional or technical perspective. When required, the Customer Support Engineer will work with or escalate within different departments at Ennov, such as Hosting, Integration, Professional Services or Developers.
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on…
Ennov User Meeting Europe 2025: Join Us in Paris This October
This October, Ennov will once again welcome customers from across Europe for our annual Europe User Meeting—a free event designed to foster collaboration, transparency, and innovation across Regulatory and Quality…
How to Move from TMF Workarounds to True Compliance
Are you still using spreadsheets, shared drives, or Word documents to manage your Trial Master File? Struggling to maintain compliance, oversight, or alignment with your CTMS and EDC? It might…
Point Solutions Are Hurting Clinical Trial Efficiency: Here’s What’s Replacing Them
The era of stitching together disconnected e-clinical tools is ending, and the transformation is accelerating faster than expected. Clinical trials face unprecedented complexity. Decentralized models are expanding, compliance pressures mounting,…
The Adoption of ICH E6(R3): Ushering in a New Era of Clinical Trial Oversight
The global clinical research landscape is undergoing a transformative shift with the adoption of ICH E6(R3)—the much-anticipated revision of the International Council for Harmonization’s (ICH) Good Clinical Practice (GCP) guidelines.…
Ennov Ready to Support Customers in EMA eCTD 4.0 Customer Pilot Phase
The EMA’s eCTD 4.0 pilot is entering its next stage, and Ennov is ready to support Marketing Authorization Holders (MAHs) who are participating. Following our own successful test submission during…
Preparing for eCTD 4.0 in Japan with a Global Pharma Leader
The Challenge Japan’s move to eCTD 4.0 has created more questions than answers for pharmaceutical companies. For one of the world’s premier pharmaceutical companies, the goal is to be ready…
Is Your Stack Holding You Back? 7 Must-Haves in a True E-Clinical Platform
Clinical trial technology is supposed to streamline operations, not slow them down. But too often, the stack becomes the source of delay. This checklist outlines 7 must-haves in a true…
FDA’s Increased Use of AI and Real-World Data
The pharmaceutical industry stands at a pivotal moment in regulatory science. As artificial intelligence transforms drug discovery and development, regulatory agencies worldwide are grappling with how to harness these powerful…
10 Clinical Trial Regulatory Changes Coming in 2025
Clinical trials are changing fast. New technologies, stricter data requirements, and pressure to speed up drug development are reshaping how we run studies. Here's what sponsors, CROs, and research sites…
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 joined by Paul Palmer, pharmaceutical…
Case Study: Vetoquinol
Discover how Ennov’s unified ecosystem eliminated vendor sprawl, standardized processes, and enabled internal teams to own their expansion, all while maintaining zero disruption to business operations.
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.
Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting data from Quality, reformatting for…
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 alignment effort to an ongoing…
Best Practices for Implementing RIM and QMS Systems in 2025
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios, success depends on implementing Regulatory…
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.
IDMP & xEVMPD Compliance: How to Manage Structured Data for EMA and Global Regulatory Success
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the terms IDMP and xEVMPD more…
Ennov Successfully Completes eCTD 4.0 Submission with EMA – Giving Customers a Head Start
Ennov is proud to be one of only four technology vendors to have successfully submitted an eCTD 4.0 test sequence as part of the European Medicines Agency’s (EMA) ongoing pilot. …
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 to SPOR, XEVMPD, SIAMED, and…
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 to SPOR, XEVMPD, SIAMED, and…
Introducing Ennov 10.4: Working Smarter Across the Life Sciences Lifecycle
Ennov 10.4 is here, thanks to the valuable feedback from our customers. This release reflects our ongoing commitment to delivering software solutions that truly bring value. Every update in 10.4…
Publishing: Common Issues and How to Improve Timelines
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you're still waiting days for your submission to be ready for review. With regulatory…
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 joined by Pierre Stanislawski, our…
Effective Training management powered by AI
Proving training records to regulatory authorities? Our AI-powered solution automatically generates compliance assessments from your documentation—no more manual effort, just click and go! What’s In It for You? 📝…
Sales Executive – Regulatory IT Solutions (Life Sciences)
As a key member of the Customer Support team, the mission of the Customer Support Engineer is to answer customer requests and issues regarding to the usage of Ennov Software, from a functional or technical perspective. When required, the Customer Support Engineer will work with or escalate within different departments at Ennov, such as Hosting, Integration, Professional Services or Developers.
Sales Executive – Pharmacovigilance/Clinical Trial IT Solutions (Life Sciences)
As a key member of the Customer Support team, the mission of the Customer Support Engineer is to answer customer requests and issues regarding to the usage of Ennov Software, from a functional or technical perspective. When required, the Customer Support Engineer will work with or escalate within different departments at Ennov, such as Hosting, Integration, Professional Services or Developers.
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.
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 compliance. In this session, we…
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 queries. The physical capture of…
Effective Training management powered by AI
Proving training records to regulatory authorities? Our AI-powered solution automatically generates compliance assessments from your documentation—no more manual effort, just click and go! Here's what you'll learn: Auto-Generated Assessments: Seamlessly align…
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, we're joined by Diarmuid Waide,…
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!
Ennov Training
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
Introducing Ennov 10.3
We are thrilled to announce the release of Ennov 10.3, delivering even greater satisfaction to our platform's users. This latest version introduces two significant new features: Enhanced AI Capabilities Ennov…
Product Management Service (PMS)
The Product Management Service (PMS) is a core element of the European Medicines Agency's (EMA) IDMP implementation. PMS provides a centralized, standardized database for managing medicinal product information across the…
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the…
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
Ennov and CognifAI Partner for AI-Driven Pharmacovigilance
Ennov, a leading provider of unified compliance software solutions for the Life Sciences, is pleased to announce a strategic partnership with CognifAI, an innovative AI solutions company specializing in pharmacovigilance.…
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out…
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that…
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK's departure from the European Union has…
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 now has its entire product…
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies - all with limited resources…
Ennov Completes the Enterprise Technology Integration from Calyx
Ennov is proud to announce the successful integration of the Enterprise Technology division from Calyx into our organization. This strategic acquisition, completed on June 1, 2024, significantly enhances Ennov’s portfolio…
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. Changes between versions can be…
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 of non-compliance in the fast-evolving…
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 businesses grapple with unique obstacles…
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned…
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR)…
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be…
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment.…
Artificial Intelligence (AI)
A branch of computer science dedicated to creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, decision-making, problem-solving, and pattern recognition.
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU Cosmetics Regulation 1223/2009 has brought…
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 Ennov to enhance consumer safety…
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer trust. Companies bear the critical…
Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division
In a landmark move for the life sciences industry, Ennov has acquired the 'Enterprise Technology' division from Calyx. This acquisition significantly expands Ennov's portfolio by integrating the advanced eClinical and…
Ennov Boosts Portfolio with Acquisition of DocShifter: The Market-Leading Document Transformation Solution
In a move that signifies a major advancement in the life sciences industry, Ennov, a leader in regulated content management solutions, has acquired DocShifter, a top provider of document automation…
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate complexity during innovation and expansion.…
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations in expanding markets. This balance…
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global regulations. Managing safety data sustainably,…
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while meeting global safety regulations. Scaling…
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that signifies not just adherence to…
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs cosmetics under the Federal Food,…
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.
Ennov Forms Strategic Partnership with ION Pharma to Elevate Quality Management in Life Sciences
Ennov is pleased to announce a strategic partnership with ION Pharma. This alliance marks the beginning of a collaborative effort that merges over two decades of expertise in electronic Quality…
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.
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41% of organizations are already actively…
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and authoritative approach. The challenge lies…
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is the mandated submission format for…
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that enables medical device companies to…
Ennov’s Agnostic Solution for IDMP, the EASI connector
Webinar Introducing Ennov's Agnostic Solution for IDMP, the EASI connector How are you going to be ready for IDMP compliance? Ennov has the answer.June 21st at 11:00 AM – 11:30…
PV-Signal Manager
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
PV-Works Vet
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
PV-Works Human
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
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