Outsourcing Pharmacovigilance activities to Regulis ensured full compliance and a successful MHRA Pharmacovigilance inspection.
A small company wished to outsource all Pharmacovigilance activities. They were in the process of obtaining an EU marketing authorisation and licence approvals in other countries around the world for their product. As an applicant and future licence holder they had to fulfil significant and complex Pharmacovigilance obligations.
There are many Pharmacovigilance activities that must be fulfilled to ensure that legal obligations are met. In addition to ensuring compliance, Pharmacovigilance has to comply with Good Vigilance Practice (GVP) and ensure that a product’s benefit risk profile is continually monitored, thereby protecting patients’ safety.
Using our deep Pharmacovigilance expertise and knowledge, we ensured that the client met all its legal obligations, allowing it to market its product in the EU and other new territories. The Pharmacovigilance obligations met included:
- Provision of a qualified, EU-based Qualified Person for Pharmacovigilance (QPPV)
- Case processing in accordance with mandatory timelines
- Maintaining a global safety database
- Weekly literature searching and monthly signal detection
- Continuous benefit risk evaluation
- Periodic safety reports.
Engaging Regulis with outsourced pharmacovigilance activities delivered:
- Protection of the product asset, allowing the company to protect patients
- Support of sales worth €3m in Year 1
- Successful MHRA Pharmacovigilance inspection with no critical findings.
Back to Case studies