DDReg Pharma- Consulting in regulatory affairs and drug safety

As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and  regulatory strategy  meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a strategic advantage. According to global regulatory experts, the ability to predict, monitor, and act on post-market data is fast becoming a benchmark for excellence in medical device oversight. While the  U.S. FDA  and the European Union (EU) both prioritize PMS, their frameworks reflect two distinct philosophies: the FDA’s reactive yet data-driven model versus the EU’s proactive, lifecycle-integrated system under MDR 2017/745. For companies with global aspirations, understanding these nuances in 2025 is essential to safeguarding brand reputation, achieve compliance, and maintain mark...

In the fast-changing field of pharmaceutical safety, incorporating Artificial Intelligence (AI) into literature monitoring for pharmacovigilance has become essential. This process involves the continuous tracking and evaluation of adverse drug reactions (ADRs) and other potential risks associated with medications. A key component of pharmacovigilance (PV) is literature monitoring, which involves reviewing scientific literature, case reports, and medical journals to gather fresh insights on ADRs and safety signals. AI, with its advanced machine learning, natural language processing (NLP), and text mining capabilities, provides a transformative solution to this task. AI can efficiently process and analyze large datasets with accuracy and speed. This technological advancement not only boosts the efficiency of literature monitoring services but also enhances its precision, ensuring that potential safety signals are detected more quickly and reliably. How AI is Transforming Pharmacovigila...