Country-Specific Compliance Queries

Obtaining a license from the South African Health Products Regulatory Authority (SAHPRA) is a crucial step for pharmaceutical and medical device companies looking to operate in South Africa. However, wait times of 6 to 18 months remain a significant bottleneck, delaying access to market and impacting revenue. With new 2025 regulatory updates coming into effect,…

Bringing therapeutic goods into the Australian market requires more than just a quality product—it demands full compliance with the country’s regulatory framework. Whether you are an importer, manufacturer, or distributor of medicines, medical devices, or health supplements, aligning with the standards set by the Therapeutic Goods Administration (TGA) is essential. Non-compliance not only risks delays…