How to integrate early access programmes into your pharma market access strategy
Access is everything for rare disease patients, who often [...]
Medical affairs vs drug commercialisation: understanding the line between science and sales
The line between medical affairs and drug commercialisation functions [...]
How to shape your market access and real-world evidence strategy with medical science liaison insights
The actionable, real-time feedback medical science liaisons (MSL) gather [...]
How to drive regulatory success with effective medical writing
Submitting a dossier to the EMA or MHRA is [...]
How to manage serious adverse events in early-phase clinical trials
Reporting serious adverse events (SAE) is integral to running [...]
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 [...]