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A deep dive into the regulatory framework for Phage Medicinal Products
Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
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Sponsors of Clinical Trials in the EU/EEA – Call for Action!
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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Digital Health Series – Part 5: Key Challenges for Software and AI as a Medical…
In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
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The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization
Following the UK’s departure from the EU In 2021, the MHRA has introduced several initiatives to foster product development and…
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Best ePRO practices – A patient centric approach
The adoption of Electronic Patient-Reported Outcomes (ePRO) in clinical research marks a significant evolution in the way patient-centered data is…
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Q&A regarding common concerns of China’s NMPA (National Medical Products Administration)
The rapid development of China’s pharmaceutical market has attracted the attention of many international health–tech companies. China has a huge…
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Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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