In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled for moving a microbiome product from R&D into first into human studies.
Published on: Nov 25, 2019
WhitepaperCMC
Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development
All our resources
More resources
blog
Digital health
Software as a Medical Device Regulated by the US FDA
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
Medical Device
Selection of a Notified Body for Medical Device Development
In the European Union (EU) the review and approval of medical devices and in vitro diagnostic medical devices often requires…
blog
Digital health
Digital Health Series: 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…
