White Papers
White Paper
According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.
White Paper
It is estimated that over 80% of prescribed medicines in the UK are generic medicines, yet they account for only one-third of the total market value. Why?
White Paper
Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
White Paper
Download our recent whitepaper to gain deep insights into the Medical Literature Monitoring of the EMA.
White Paper
Download our recent whitepaper to gain deep insights into the Monitoring Compliance with Safety Exchange Agreements.
White Paper
Download our recent whitepaper to gain deep insights into the Implementation of Eudravigilance Data Analysis System (EVDAS) in signal detection.
White Paper
Download our recent whitepaper to gain deep insights into the QMS aspects of the Medical Device Regulation.
White Paper
Download our recent whitepaper to gain deep insights into the legal status switches in the UK.
White Paper
Download our recent whitepaper to gain deep insights into the mutual recognition of inspections of medicinal product manufacturers between the EU and the USA.
White Paper
Download our recent whitepaper to gain deep insights into the medical device regulations and their implications on device vigilance.
White Paper
Download our recent whitepaper to gain deep insights into the new responsibilities for importers, distributors and authorized representatives for medical devices.
White Paper
Download our recent whitepaper to gain deep insights into EU drug registration procedures.




