Pharmacovigilance Compliance
At Quality and Vigilance, we are proud in providing quality services in Pharmacovigilance (PV) as well as bespoke auditing services refer to tailored or customized audit solutions designed to meet the specific needs and requirements of organisations. It involves customized, and client-centric approach which considers the unique characteristics of business requirement, its risks, and complexities as well as patient safety.
PV Process audits
These audits include but not limited to:
- Adverse Event (AE) case processing
- Risk Management Plan (RMP)
- Literature services
- Aggregate report e.g. PADER, PBRER/PSUR, DSUR
- US NDA/BLA/PMA Annual Report
- PV Database audit (including CSV components)
- Pharmacovigilance System Master File (PSMF)
- Qualified Person for Pharmacovigilance office
- E2B and non-E2B ICSR submission
- PV Agreements/SDEA process
Internal audits
- Country Organization audits
- Global PV organization audit
- Regional PV office
- Regional Regulatory Affairs audit
- Medical Affairs office audit
- Global/regional/local commercial department audit
External audits
- Business Partner audits
- Distributor/Wholesaler audit
- PV vendor audits (e.g. Literature services, translation, DHCP distribution, case processing, ICSR submission, etc.)
- PV resource/staff vendor audit
Inspection Support
PV inspections are conducted by the Health Authorities to evaluate and assess the compliance with regulations, and standards.
We provide support in:
- Preparing logistics
- Pre-Inspection preparation
- Compliance assessment
- Training and Educating to staff
- Document review
- Corrective/Immediate Action planning
- Post-Inspection follow-up activities
Qualified Person for Pharmacovigilance (QPPV)
Quality and Vigilance is feeling pride in outsourcing the QPPV services to small and med-sized pharmaceutical companies. Our global network is already providing QPPV services in the country (UK, France, Germany, etc.), European Union (EU), EMEA, and APAC countries.
QPPV services include (but not limited to):
- Establishing, maintaining and overseeing PV systems and processes
- Acting as a single point of contact for Health Authorities for 24-hours
- Answering requests from Health Authorities
- Providing Health Authorities with requested information relevant to product safety
When connected with us, you aren’t fostering growth in the quality of your business alone. We have your back and put in our best to contribute to the growth of your entire systems and processes. So, if you are looking for the right service provider that’ll help you build a good GxP quality presence, we are just a call away.