In this blog post, WBR’s principal consultant, Dr. Ash Ramzan, gives his insight into trends to look out for in the life sciences sector in 2021.
Without a doubt, 2020 has been the most impactful year in living memory for the life sciences sector. In the UK, not only has the race been on to secure treatments and preventions for the coronavirus pandemic, but the sector has also had to prepare for the impact of Brexit.
We’ve seen a big increase in clients looking to secure supply chains and needing assistance with their Good Manufacturing Practice (GMP) and quality audits, ahead of the UK leaving the EU.
We’ve naturally also recognised a push in new products, including Covid tests, vaccine developments, and the repurposing of anti-viral drugs to battle the virus.
The UK’s new Medical Devices Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) has implemented a number of additional requirements for GB manufacturers.
As such, WBR’s work as a regulatory affairs consultancy has been incredibly busy throughout the year, with no signs of slowing down.
For 2021 and beyond, we will continue to see a trend in digitisation of audits and the use of real-time data reporting, as opposed to manual submissions. We will also see regulators — including MHRA — extend the accelerated review parameters that were brought in as a response to Covid-19, including rolling reviews of clinical trials.