Development safety update report writing mistakes that trigger regulator questions (and how to prevent them)
The development safety update report (DSUR) is often the [...]
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 [...]
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 [...]
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 [...]
Employing advanced analytics and artificial intelligence in rare-disease pharmacovigilance
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
The limits of traditional pharmacovigilance in rare diseases
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
How to choose the right functional service provider operating model for scaling your drug development programme
For small to mid‑sized biotech and pharma companies, building [...]
How a functional service provider approach can support your clinical study
Small and mid-sized biotechs and pharma companies live and [...]