Specialist PV Support Transforms Safety For Orphan Medicinal Products

A United Kingdom–based company developing two orphan-designated therapies required a pharmacovigilance partner with deep expertise in navigating the complex regulatory landscape for centrally authorized orphan medicinal products in Europe. After experiencing limitations with a previous provider, the company transitioned to a new partner to better meet its needs.

Following a successful safety database migration in 2022, the new partner assumed responsibility for critical functions, including global pharmacovigilance system maintenance, local PV services across the EU and Switzerland, and support for clinical trials. A dedicated clinical trial team now collaborates closely with the company’s Clinical Trial Unit, helping to ensure consistent, high-quality safety oversight across all development activities.