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 [...]
What you need to know about marketing authorisation holder requirements in the UK/EU
In clinical research and drug development, regulatory submissions are [...]
How can marketing authorisation holders overcome these 5 post-approval regulatory affairs challenges?
Bringing a new drug to market doesn't end with [...]