Your essential checklist for an effective regulatory submission
Bringing a new drug to market is a complex, [...]
10 common pharmacovigilance inspection findings and their implications
Pharmacovigilance (PV) plays a crucial role in assuring patient [...]
3 common MHRA marketing authorisation challenges (and how to solve them)
Biotech and pharmaceutical companies face numerous challenges when commercialising [...]
Why you need a specialist for regulatory submissions in rare disease clinical trials
The path to regulatory approval for rare disease treatments [...]
A strategic guide to navigating your orphan drug designation application
Innovation is often the key to unlocking life-changing treatments [...]
What you need to know about marketing authorisation holder requirements in the UK/EU
In clinical research and drug development, regulatory submissions are [...]
Navigating the complexity of compliance review of UK/EU product communications for rare diseases
By Marcelo Vaz, Vice President of Medical Services at [...]