All Posts
Pharma & Biotech Reg Strategy
EU AI Act Compliance
Regulatory Affairs Leadership
Medical Device Regulation
AI in Pharma & MedTech
Clinical Trials for AI Drugs
Global Regulatory Intelligence
CE Marking & UKCA Compliance
Market Access Consulting

Clinical Trials for AI Drugs

Expert guidance on clinical trials for AI-enabled drug discovery. Covers FDA and EMA requirements, Good Machine Learning Practice (GMLP), trial design, and regulatory submissions for AI therapeutics.

Document with charts on it and a person in the background

Mastering FDA Compliance Consulting from the UK

Why FDA Compliance Consulting is Essential for UK Biotech and SME Companies. For biotech and SME companies, resources are often limited, and regulatory missteps can be costly. FDA compliance consulting offers tailored support that aligns with your business goals and product innovation timelines.

Camilla Costa

Dec 8, 20254 min read

Innovative approaches to neurological disease treatment are highlighted in this digital illustration, which presents a conceptual representation of brain wave modulation and neural network connectivity.

Navigating the EU AI Act: Implications for Neurological AI Systems

The EU AI Act (Artificial Intelligence Act Regulation EU 2024/1689), which came into force on 1 August 2024, establishes a harmonised framework for regulating AI systems. It impacts the use of AI in medical settings, particularly when integrated with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Camilla Costa

Jul 27, 20255 min read

AI in Pharma: Job Killer or Opportunity for Innovation and Growth?

In this article, we will explore how AI is reshaping the pharmaceutical landscape and examine its implications for the workforce, presenting a balanced view on the potential benefits and challenges ahead.

Camilla Costa

Jul 21, 20254 min read

Structuring Clinical Trials for AI-Enabled Drug Discovery Platforms: A Comprehensive Guide

In the fast-paced world of drug discovery, artificial intelligence (AI) has become essential, transforming the way researchers identify...

Camilla Costa

May 12, 20254 min read