Legal Representation in the EU / Responsible Person in EudraVigilance
Clinical Safety
Pharmaceutical companies outside the European Union (EU) are required to appoint a legal representative within the EU to ensure compliance with EU pharmacovigilance regulations and facilitate communication with regulatory authorities.
Additionally, a Responsible Person in EudraVigilance must be designated to oversee the submission of Individual Case Safety Reports (ICSRs) and maintain data quality within the EudraVigilance system.
PVpharm provides reliable Legal Representation and Responsible Person (RP) services for pharmacovigilance purposes, ensuring compliance with EU legislation and maintaining effective communication with Regulatory Authorities.
Our services include:
- Legal representative appointment: Acting as legal representative in the EU, serving as the primary contact for regulatory agencies
- EudraVigilance registration: setup and management of your company in the EudraVigilance system
- RP nomination and provision: Responsible Person role for accurate and timely submission of ICSRs to EudraVigilance
- EU PV legislation compliance: Ensuring compliance with EU pharmacovigilance legislation and guidelines
- Audit/inspection readiness: Support during inspections and audits related to legal representation and EudraVigilance activities
