Compliance with the South African Health Products Regulatory Authority (SAHPRA) is essential for companies in pharmaceuticals, medical devices, complementary medicines, and related health sectors. Our consulting services help businesses navigate SAHPRA’s complex regulatory framework to achieve faster approvals, maintain compliance, and ensure successful market access.

Our Services

• Product Registration and Licensing: Preparation and submission of registration dossiers for medicines, medical devices, and complementary products in line with SAHPRA requirements.
• Regulatory Strategy and Classification: Guidance on product classification, optimal regulatory pathways, and documentation to streamline approvals.
• Dossier Compilation and Review: Assistance with compiling and reviewing CTD-format dossiers and technical documentation.
• Variations, Renewals, and Post-Approval Support: Management of product updates, renewals, and amendments to maintain compliance.
• GMP and Quality Compliance: Support with Good Manufacturing Practice (GMP) audits, inspections, and quality system readiness.
• Pharmacovigilance and Post-Market Surveillance: Development of systems for adverse event reporting and ongoing product monitoring.
• Training and Advisory: Tailored training on SAHPRA processes, new guidelines, and compliance best practices.

Why Choose Us

• Deep understanding of SAHPRA regulations and procedures.
• Experienced team of professionals.
• Proven success in product registrations and renewals.
• Practical, efficient, and compliant solutions tailored to South African requirements.

Get in Touch

Accelerate product registration and ensure full compliance with SAHPRA regulations.
Contact us today to learn how our SAHPRA Regulatory Consulting Service can help your business achieve regulatory success in South Africa.