top of page


Registering Medical Devices in Europe: Key Steps for Success
Navigating the regulatory landscape for medical devices in Europe can feel daunting. However, with the right approach and clear understanding, it becomes a manageable process that opens doors to one of the world’s most significant healthcare markets. I want to share practical insights and step-by-step guidance to help you confidently move through the process of registering medical devices in Europe. This will empower your company to bring innovative products to patients faste

BC Regulatory Blog
Dec 22, 20254 min read


EU AI Act and Its Application in Developing Rare Disease Therapies for Neurological Disorders
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


AI in Pharma 2025: Who’s Leading the Charge and Why It Matters
The convergence of artificial intelligence and pharmaceutical innovation is no longer a distant vision; it’s today’s reality. With a projected market size of $116.49 billion by the end of 2025 and a 27% compound annual growth rate (CAGR), AI in pharma is reshaping everything from drug discovery to diagnostics.

Camilla Costa
Jul 4, 20253 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


Unlocking Key Resources for Navigating FDA and EU Regulations in Digital Health
The digital health landscape is evolving quickly, thanks to advances in technology like artificial intelligence (AI) and machine learning...

Camilla Costa
Nov 6, 20245 min read
bottom of page