Post-approval risk management plan updates: what changes, who owns it, and how to avoid compliance issues
In the EU and UK, a risk management plan [...]
Drug commercialization: how to build a lean EU and UK launch model without losing control
European marketing authorization can feel like the summit. Years [...]
What to lock down 12–18 months before submitting your marketing authorization application in the EU/UK
The European Medicines Agency (EMA) review clock starts from [...]
Understanding EU and UK drug labelling requirements before you launch
For many emerging biotech and pharma companies, regulatory approval [...]
The 5 key stages of the drug commercialisation process explained for first-time sponsors
Between 2020 and 2023, 173 innovative medicines received marketing [...]
How to craft an effective EU pharma strategy for small to mid-sized biotech and pharma companies
The European market offers a large patient base, strong [...]
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 [...]
3 common UK MHRA marketing authorisation challenges (and how to solve them)
Biotech and pharmaceutical companies face numerous challenges when commercialising [...]