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Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.
Real-World Data: Possible Applications, Challenges & Emerging Role within Regulatory Affairs.
Clinical trials are historically associated with extensive inclusion and exclusion criteria, to deliver results which reflect an acceptable level of validity.
Orphan Drug Designation in the US, EU & GB.
A rare disease is any disease that affects a small percentage of the population, although the exact definition varies across jurisdictions. While each disease is rare, collectively, these disorders affect 6–7% of the population in the developed world.
Making the Most of Opportunities to Interact with The US FDA.
FDA offers formal advice at no cost to developers of medicines regulated by both CDER and CBER, with the aim of supporting medicinal product development from Phase 1 through to marketing.
Post-Brexit Transition Period Changes. UK’s New Regulatory Landscape.
Following the end of the United Kingdom’s Brexit transition period on 31 December 2020, the MHRA will implement a number of changes as the UK forges its new regulatory system.