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.
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
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
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
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
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
