In today’s rapidly evolving digital landscape, IT governance is essential for ensuring that technological investments align with business objectives. Within the pharmaceutical and biotech industries, where compliance with regulations such as GAMP5 and GDPR is critical, IT governance provides a structured framework to manage risks, optimize resources, and enhance information security.

When a biotech company acquires another, integrating all GxP-related data and systems can be particularly challenging. M&A integration comes with unique complexities and several critical questions.

Regulatory compliance in the pharmaceutical industry is complex and constantly evolving. 

Keeping up with changing regulations, managing large volumes of documentation, and 

ensuring data accuracy can be overwhelming. Traditionally, these tasks require a lot of 

manual effort, increasing the risk of errors and delays. This is where AI agents come in. By 

automating key regulatory processes, they help pharma companies work more efficiently, 

reduce risks, and speed up approvals. 

The European medicines regulatory network aims to enable regulatory systems in the European Union (EU) to use the capabilities of artificial intelligence (AI) while managing the risks. Capabilities include personal productivity, process automation, better insights into data and decision-making support for the benefit of public and animal health.

Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

Draft Guidance for Industry and Other Interested Parties

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).