New drug approvals: how to de-risk the transition from early development decisions to approvable EU/UK submissions
The European Medicines Agency (EMA) and the Medicines and [...]
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 [...]
6 common pediatric investigation plan challenges US companies face when seeking EU/UK marketing authorization
If you're preparing to seek marketing authorization in the [...]
Strengthening clinical governance for decentralised elements in early-phase clinical trials
Remote engagement is no longer a ‘nice to have’ [...]
Minimising safety concerns in early-phase clinical trial application submissions
Early-phase clinical trials are among the most consequential steps [...]
Understanding EU and UK drug labelling requirements before you launch
For many emerging biotech and pharma companies, regulatory approval [...]
Integrating strategic functional consulting expertise to accelerate your drug development timeline
Speed is rarely achieved by pushing one function harder. [...]
Strengthening rare-disease pharmacovigilance with curated real-world data
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
Navigating the first regulatory milestone: how to prepare a successful clinical trial application
Submitting a clinical trial application (CTA) is a pivotal [...]
The 5 key stages of the drug commercialisation process explained for first-time sponsors
Between 2020 and 2023, 173 innovative medicines received marketing [...]