Pharmafile PV Services
Pharmafile PV Services Limited is a pharmacovigilance consultancy dedicated to providing comprehensive safety monitoring services for the pharmaceutical, veterinary, medical device, healthcare, and cosmetic industries. Their mission is to deliver high-quality, tailored vigilance services, including QPPV support, to enhance public health and ensure compliance. They emphasize integrity, client focus, expertise, and continuous improvement in their operations.
Industries
Nr. of Employees
small (1-50)
Pharmafile PV Services
Ashbourne, Derbyshire, United Kingdom, Europe
Services
End-to-end pharmacovigilance services including EudraVigilance registration, RMP and PSMF development, safety database management, signal detection, PSUR/PBRER preparation, inspection support and QPPV provision.
Post-market surveillance and regulatory reporting support for cosmetic products to assist the Responsible Person in meeting compliance obligations under EU cosmetics regulation.
Evaluation of device-related adverse incidents and assistance with dissemination of competent authority reports and corrective actions.
Provision of Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV roles and associated oversight for EU operations.
Provision of medical review, case narratives and systematic literature searching to identify safety information for inclusion in safety reports.
Safety monitoring and regulatory reporting services tailored for veterinary medicinal products.
End-to-end pharmacovigilance services including EudraVigilance registration, RMP and PSMF development, safety database management, signal detection, PSUR/PBRER preparation, inspection support and QPPV provision.
Post-market surveillance and regulatory reporting support for cosmetic products to assist the Responsible Person in meeting compliance obligations under EU cosmetics regulation.
Evaluation of device-related adverse incidents and assistance with dissemination of competent authority reports and corrective actions.
Provision of Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV roles and associated oversight for EU operations.
Provision of medical review, case narratives and systematic literature searching to identify safety information for inclusion in safety reports.
Safety monitoring and regulatory reporting services tailored for veterinary medicinal products.
Expertise Areas
- Pharmacovigilance system implementation and management
- Regulatory compliance and submissions for safety reporting
- Risk management planning and benefit–risk assessment
- Safety data management and case processing
Key Technologies
- Regulatory adverse event reporting systems (EudraVigilance)
- Safety database management systems
- Biomedical literature databases (PubMed, EMBASE, MEDLINE)
- Signal detection methodologies and statistical evaluation