blog
Digital health
Digital Health Series – Part 2: Software as a Medical Device Regulated by the US…
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
Case study
CMC
How to Optimize CMC for Successful Cultured Meat Product Development
Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
blog
Digital health
Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
webinar
Brexit
Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
blog
Regulatory strategy
How can you take advantage of China’s accelerated regulatory pathways for your product development?
Global drug innovation in the East has significantly increased in recent years. China is one of the major players and…
