Are you concerned about the legislative requirements around Pharmacovigilance? If you need help to meet the your legal obligations or just need some advice on where to start, Purple Vigilance can help.
Our Pharmacovigilance Consultancy clients are established/ start-up pharmaceutical companies and Contract Research Organisations who require additional Pharmacovigilance resources delivered by experts in a timely manner. Our services are cost-effective, and we can save your company permanent staffing costs and expensive recruitment fees.
Our skills and services include:
- Provision of UK Qualified Person for Pharmacovigilance (QPPV)
- Regulatory compliance
- Expert advice on Pharmacovigilance system set up
- Provision of Responsible Person for EudraVigilance
- Data entry and maintenance of product details in XEVMPD
- Pharmacovigilance process review
- Standard Operating Procedure (SOP) & Work Instruction (WI) preparation & critical review
- Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Interim Pharmacovigilance support during busy periods/ staff shortage
- Pharmacovigilance training including EU/ UK QPPV training
- Pharmacovigilance system and document audits
- Safety signal review & evaluation
- Advice on the Eudravigilance registration process
- Periodic Safety Update Report/ Periodic Benefit-Risk Evaluation Report (PSUR/PBRER) preparation & critical review
- Preparation or review of Safety Data Exchange Agreements
- Support prior to & during Pharmacovigilance Regulatory Inspections
- Corrective action/ preventive action (CAPA) preparation
- Guidance & advice during integration of Pharmacovigilance systems following company mergers/ acquisitions
- Literature searching services
Contact us for more information.
Purple Vigilance Limited
Safety. Compliance. Solutions. Support.