Safeguarding Patients Through Regulatory-Compliant Safety Systems
GH Strategies develops pharmacovigilance systems engineered to meet SAHPRA, EMA, and WHO standards — strengthening compliance, safety oversight, and inspection readiness.
What We Offer
Pharmacovigilance System Development & Implementation
Design and end-to-end setup of SAHPRA-compliant PV systems, including governance structures, SOPs, reporting workflows, quality controls, and operational safeguards.
QPPV & Deputy QPPV Services (South Africa)
Local, qualified QPPV support for MAHs needing end-to-end oversight of their PV system, including compliance monitoring, system governance, PSMF maintenance, and inspection readiness.
Adverse Event Reporting & Case Management
End-to-end collection, triage, assessment, and timely reporting of adverse events in accordance with SAHPRA timelines and international reporting obligations.
Signal Detection & Risk Management Planning
Continuous monitoring of safety data to identify emerging signals, assess risk, and develop Risk Management Plans (RMPs) and post-market safety commitments.
Safety Database Setup & Maintenance
Configuration and management of validated safety databases for compliant data entry, case tracking, reconciliation, analytics, and regulatory reporting outputs.
Pharmacovigilance Audits & Inspection Readiness
Comprehensive readiness assessments, mock inspections, QMS alignment, PSMF reviews, SOP gap analysis, and CAPA planning to meet SAHPRA and global inspection expectations.
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Why Choose GH Strategies for Pharmacovigilance Support
Patient Protection
Regulatory Confidence
Risk Prevention
Pharmacovigilance Standards Built for Regulatory Precision
Pharmacovigilance frameworks engineered to meet SAHPRA expectations, strengthen system governance, and ensure full alignment with international vigilance requirements.
Frequently Asked Questions (FAQs)
Pharmacovigilance is the scientific and regulatory process of monitoring the safety, quality, and effectiveness of medicines and health products after they reach the market. SAHPRA requires Market Authorisation Holders to maintain a pharmacovigilance system that identifies, evaluates, and reports safety risks to protect patient health. GH Strategies supports end-to-end PV compliance for regulated products.
Companies must report adverse drug reactions (ADRs), serious and unexpected events, product quality complaints, medication errors, and safety-related findings from clinical or post-marketing settings. SAHPRA expects timely reporting according to defined timelines as well as ongoing risk evaluation through PSURs, RMPs, and signal detection activities.
Yes. Medical devices and IVDs require post-market surveillance, vigilance reporting, tracking of device failures, and investigation of incidents or near-incidents. GH Strategies helps organisations establish compliant device vigilance systems, prepare reporting documentation, and respond to SAHPRA queries.
A PSMF is a comprehensive document describing the structure of your pharmacovigilance system, safety processes, quality controls, personnel responsibilities, and global safety oversight. Most regulatory authorities, including SAHPRA, require an updated PSMF for Market Authorisation Holders, and it must be readily available for inspection. GH Strategies develops and maintains PSMFs aligned to regulatory expectations.
Serious or unexpected adverse events must be reported within strict regulatory timelines – often 15 days for expedited reports, with shorter timelines for specific product categories. Failure to meet these timelines is a common compliance finding. GH Strategies builds workflow systems and SOPs that ensure timely, accurate, and audit-ready reporting.
We assist with safety inspection readiness, mock inspections, PSMF reviews, PV quality assessments, SOP updates, CAPA planning, and evidence preparation for SAHPRA, ISO, and global regulatory audits. Our approach strengthens system performance, mitigates compliance risks, and prepares teams for both announced and unannounced inspections.
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