Pharmacovigilance & Risk Management
Our pharmacovigilance services help pharmaceutical companies monitor and manage the safety of their products throughout the entire product lifecycle, from clinical development to post-marketing surveillance.
Key Services
Adverse Event Reporting and Case Management
Comprehensive intake, processing, and reporting of adverse events to regulatory authorities in compliance with global requirements.
Pharmacovigilance Training
Specialized training programs for pharmaceutical staff, healthcare professionals, and other stakeholders on drug safety monitoring and reporting.
Compliance Audits
Thorough assessment of pharmacovigilance systems against regulatory requirements and industry best practices.
Quality Risk Management
Implementation of risk management plans and strategies to identify, assess, and mitigate product safety risks.
Why Choose Our Pharmacovigilance Services
Our pharmacovigilance team brings extensive experience in drug safety across multiple therapeutic areas and regulatory environments. We provide:
Scalable solutions for companies of all sizes
Expertise in both global and local African regulatory requirements
Technology-enabled solutions for efficient case management
Comprehensive Pharmacovigilance
Our comprehensive adverse event reporting and management system includes
Case intake and processing
Medical assessment and coding
Regulatory reporting to health authorities
Signal detection and evaluation
We ensure your pharmacovigilance systems comply with global regulations:
FDA and EMA requirements
ICH guidelines
SAHPRA pharmacovigilance requirements
