There are moments in every industry when progress demands a new way of thinking. For GH Strategies, that moment arrived when the team looked beyond consulting and saw an even greater opportunity to educate, empower, and elevate the very professionals…
Every medicine, vaccine, and medical device carries the promise of better health, but also the responsibility of ensuring safety. In South Africa, the science of pharmacovigilance has become essential to maintaining that balance. It is the discipline that watches over…
In April 2025, the South African Health Products Regulatory Authority (SAHPRA) formally announced that medical device establishments applying for a new, renewed, or amended establishment licence must hold valid ISO 13485 certification. This policy aligns South Africa’s regulatory framework with…
Clinical trials depend on precision – not only in research design but also in how medicines, materials, and data move through an intricate global network. At the heart of every successful study lies a supply chain that functions flawlessly, ensuring…
Inspection readiness has become one of the most critical success factors for pharmaceutical, biotech, and medical device companies in South Africa. With the South African Health Products Regulatory Authority (SAHPRA) increasing its inspection activities and global sponsors demanding rigorous compliance…
South Africa’s pharmaceutical and clinical research sector has grown rapidly over the last decade. The country now supports large-scale clinical trials, vaccine manufacturing, and supply of critical medicines across sub-Saharan Africa. With this growth, however, comes increased regulatory scrutiny. The…
Across Africa, the MedTech industry is undergoing a quiet transformation. What was once a fragmented field defined by regulatory hurdles and import dependency is becoming a space of innovation, standardization, and strategic growth. Behind this shift lies a growing realization:…
Introduction South Africa’s medical device and diagnostics sector is expanding rapidly. From local innovators developing diagnostic kits to multinationals manufacturing implantable devices, the industry plays a vital role in patient care and economic growth. But with growth comes scrutiny. Regulators,…
Data integrity has become one of the most scrutinised areas in pharmaceutical manufacturing and clinical research inspections globally. In South Africa, regulators such as the South African Health Products Regulatory Authority (SAHPRA), together with international sponsors and donors, increasingly focus…
Introduction South Africa’s pharmaceutical industry is a critical hub for supplying medicines across the country and the wider sub-Saharan Africa region. From antiretrovirals and vaccines to investigational trial products, millions of patients depend on safe, effective, and timely delivery. But…