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![Post thumbnail Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/02/UK-binary-code-233x260.jpg)
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…
![Post thumbnail The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/02/blog-post-photo-1-e1707214570679-233x260.jpg)
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…
![Post thumbnail Best ePRO practices – A patient centric approach](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/01/ePro-blog-post-photo-233x260.png)
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…
![Post thumbnail Q&A regarding common concerns of China’s NMPA (National Medical Products Administration)](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/01/NPMA-233x260.jpg)
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…
![Post thumbnail Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products”](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/11/shutterstock_676738099-233x260.jpg)
Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…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…
![Post thumbnail Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/10/shutterstock_425582359-233x260.jpg)
Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU
Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
![Post thumbnail The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims – Part 2](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/09/图片1-233x260.png)
The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
![Post thumbnail FDA Meeting Series: How, When and What – INTERACT Meetings](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2022/07/FDA-Meetings-Series-2nd-site-version-233x260.png)
FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…