The aim was to disrupt the diagnostics market with a lancing system that would significantly improve the patient’s experience. Our development and regulatory teams helped our client launch the first FDA & CE approved device for fully automated, virtually pain-free lancing.
CDP’s partner QuantuMDx has now embarked on £11 million scale-up to mass manufacture of their Q-POC™ device.
The Covid-19 pandemic has presented a time-limited but immense window of opportunity for diagnostics companies. Changes in regulation and increased levels of investment are enabling radical innovations to have real impact, but only if they can be fast-tracked into new products which are cost effective and compelling to users. In…
Models are everywhere – anyone who has played a computer game has encountered a model, but in a pandemic, mathematical models are vital for understanding the dynamics of transmission, disease progression, healthcare needs and the overall outcome on the population. Recent real world events have shown that critical decisions are…
Jez shares some of the approaches we use at CDP to make sure our teams can work effectively in virtual meetings.
Cheaper DNA sequencing may provide the impetus for public and private sectors to work together to unlock the benefits held within the nation’s genomes.
Louise reflects on upcoming changes and their potential impact.
James Baker, partner at Cambridge Design Partnership, considers the future for AI in the real world with help from a sideways look at its portrayal on the big screen.
RAPS (Regulatory Affairs Professionals Society) publish a set of excellent “Fundamentals” books, each covering a different regulatory context: US, EU, Canadian and International (which covers other markets), (see here). These books detail the key aspects of the regulations for pharmaceuticals, medical devices and IVDs (In vitro diagnostics) with considerations about…
WEBINAR 6 steps to build winning biosimilar defence strategies through user and technology mapping With Pari Datta 14 MAY 2019 The market for biosimilars is growing rapidly at over 30% per annum, as increasingly more biological drugs are going off-patent and the rate of regulatory approvals increases. The major high-value…
CDP has just opened a brand-new biological laboratory at its Cambridge HQ, certified to allow research on containment level 2 biological hazards such as micro-organisms, blood and other body products. ‘We are delighted to announce that our new lab has now received approval from the UK Health and Safety Executive,’…
Biosimilars are taking on the multi-billion-dollar blockbuster drugs of today, with some sources suggesting that the market will be worth greater than $20 billion per annum within the next couple of years. The growth is being driven by factors such as healthcare systems looking to reduce costs and the growing…