Implementation of QPPV & LCPPV Services

Client Challenge
A multinational pharmaceutical company needed to ensure compliance with pharmacovigilance regulations across multiple regions, including Europe, Africa, and the Middle East. The client required the appointment of Qualified Persons for Pharmacovigilance (QPPV) and Local Pharmacovigilance Contacts (LCPPV) to oversee safety monitoring and regulatory compliance. However, they lacked the resources and expertise to manage these roles effectively across diverse regulatory environments.

PVigi’s Solution
PVigi provided end-to-end QPPV and LCPPV Services to ensure seamless pharmacovigilance oversight and regulatory compliance across all regions. Our approach included:

Appointment of QPPV and LCPPV:

Europe: Germany, France, UK, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Poland, Sweden, Denmark, Norway, Finland, Portugal, Greece, Ireland.

Africa: South Africa, Egypt, Morocco, Algeria, Tunisia, Nigeria, Kenya, Ghana, Ethiopia, Uganda, Tanzania.

Middle East: Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain, Jordan, Lebanon, Iraq, Iran, Yemen.

Regulatory Compliance

Pharmacovigilance System Management

Training and Support

Outcome
Seamless Compliance: The client achieved full compliance with pharmacovigilance regulations across all targeted regions.

Efficient Oversight: The appointed QPPVs and LCPPVs ensured effective monitoring and management of safety data.

Regulatory Trust: The client built strong relationships with regulatory authorities, leading to smoother approvals and inspections.

Global Expansion: The client successfully expanded its market presence in Europe, Africa, and the Middle East, supported by PVigi’s expertise.