webinar
Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
blog
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…
blog
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…
blog
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…
blog
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…
webinar
Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
blog
The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the competitive race for innovation and marketing, a manufacturer may develop new technological products with the objective of using…
publication
Regulatory Trends in the Nonclinical Development of Viral Vector-Based Gene Therapies: A Benchmark Analysis of…
As it is often the case with innovative technologies, regulatory agencies are highly demanding in product safety demonstration from those…
