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
December 19, 2025
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
November 20, 2025
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,
October 28, 2025
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
September 12, 2025
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
September 11, 2025
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
September 5, 2025
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
September 2, 2025
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
July 22, 2025
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
July 15, 2025
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)
July 10, 2025
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
July 9, 2025
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
July 9, 2025
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
July 8, 2025
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
July 1, 2025
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
June 24, 2025
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
June 20, 2025
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,
June 17, 2025
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
May 23, 2025
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
May 14, 2025
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
October 30, 2024
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
October 7, 2024
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
September 18, 2024
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
July 24, 2024
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
June 28, 2024
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
May 22, 2024
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
April 22, 2024
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
April 2, 2024
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
March 26, 2024
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
March 18, 2024
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
March 4, 2024
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
January 10, 2024
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
January 9, 2024
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
January 6, 2024
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
January 5, 2024
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
December 20, 2023
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
December 4, 2023
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%
September 21, 2023
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
September 5, 2023
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
July 28, 2023
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
June 7, 2023
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
April 13, 2023
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
April 12, 2023
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
April 11, 2023
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
February 24, 2023
Unlocking the Future of Healthcare: Insights from the 2023 Gartner Report on Digital Transformation
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A
February 9, 2023
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
January 1, 2023
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
November 2, 2022
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
October 5, 2022
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
August 29, 2022
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
July 21, 2022
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
April 14, 2022
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
February 23, 2022
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
February 7, 2022
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
January 14, 2022
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
July 19, 2021
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
March 24, 2021
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
February 24, 2021
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
February 2, 2021
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
January 19, 2021
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
October 19, 2019
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
October 10, 2019
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data
January 16, 2018
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