Bridging the Compliance Gap: IDMP Gap Analysis for the transition from xEVMPD to PMS 

This Insight is part of our AI in Pharma Series, where we share use cases for AI & automation in a highly regulated reality. With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated AI solution to solve them.

Regulatory Affairs Strategy for Small Pharma and Biotech

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This Insight, written by Pharma IT Director of Regulatory Affairs (RA) Anne Louise Kirkegaard, highlights the importance of a solid RA strategy for small pharma and biotech companies. Plus tips to ensure market success and compliance.

What is NIS2?

In this blog post, or Pharma IT Insight, we describe the EU's new NIS2 Directive including the life science companies that are now in scope

This Insight, written by Pharma IT Cybersecurity expert Steen Lindebjerg provides a high level overview of the EU’s NIS2 Directive, including key changes in the old NIS legsilation and steps to take towards compliance.

AI in Pharma: Commercial Use Cases

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This Insight is part of our AI in Pharma Series, where we share use cases for AI in a highly regulated reality. Pharma IT’s Director of Commercial & Medical Consulting discusses the use of AI in the commercial stage of the pharmaceutical life cycle. This includes use cases in promotional content ideation, creation, review, and approval.

CMC vs GMP: What’s the difference?

This Insight describes the similarities and differences between CMC and GMP. Both are crucial to guarantee drug product quality, safety, and consistency.

5 Microsoft Word Hacks for Regulatory Writing 

Microsoft Word is a widely utilized tool for creating and editing regulatory documents. However, its full potential is often overlooked. In this Insight, Principal Medical Writer Katja Heinemeier provides 5 Microsoft Word Hacks for regulatory writers to increase writing speed & efficiency.