Category: Regulatory – Blog

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

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

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

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

Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics

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%

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

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

This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this