As regulatory requirements become more complex across global markets, life sciences organizations face mounting pressure to deliver accurate submissions faster while maintaining strict regulatory compliance.
Why Small Life Sciences Teams Need a RIM System Small pharmaceutical and biotechnology companies face the same regulatory expectations as large global enterprises, but
Medical technology companies operate in one of the most complex regulatory environments in the world. From device development through post-market surveillance, regulatory teams must manage global registrations,
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The details of guidance, submission formats, and data expectations evolve, but the
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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%
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
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
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
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
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
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
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
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
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
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
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
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,
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
