Regulatory Intelligence Success

Client Challenge
A global pharmaceutical company needed to ensure compliance with pharmacovigilance regulations across multiple regions, including the Middle East, North Africa, and Europe. The client faced challenges in staying updated with evolving regulatory requirements and lacked the resources to monitor and interpret these changes effectively. They required a partner with extensive regulatory intelligence and high country coverage to ensure seamless compliance.

PVigi’s Solution
PVigi provided Comprehensive Regulatory Intelligence Services with high country coverage, ensuring the client remained compliant across all regions. Our approach included:

Regulatory Monitoring

Continuously monitored regulatory updates and changes in pharmacovigilance requirements across 25+ countries in the Middle East, North Africa, and Europe.

Covered key regions, including:

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

North Africa: Egypt, Morocco, Algeria, Tunisia, Libya, Sudan.

Europe: Turkey, Germany, France, UK, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Poland.

Regulatory Interpretation

Tailored Compliance Strategies

Timely Reporting

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

Proactive Updates: PVigi’s continuous monitoring ensured the client was always informed of regulatory changes, avoiding potential penalties.

Enhanced Efficiency: The client’s pharmacovigilance operations became more efficient, with streamlined processes and reduced risks.

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