Overview
Our Regulatory Affairs service provides comprehensive support for pharmaceutical product registration, compliance, and lifecycle management. We specialize in navigating the complex regulatory landscape across South Africa and the broader African continent. We ensure your products meet all regulatory standards for successful market entry and sustained compliance.
With deep expertise in NRAs requirements and alignment with WHO guidelines, we ensure your products meet all regulatory standards for successful market entry and sustained compliance.
Key Services and Products
Products
Pharmaceuticals – Scheduled, complementary, and veterinary medicines.
Scheduled Medicines – Regulatory guidance and services aligned with SAHPRA, and other NRAs across Africa.
Complementary Medicines – Regulatory guidance and services for Herbal and alternative therapies
Veterinary Medicines – Regulatory guidance and services for Animal health products.
Medical Devices – Diagnostic tools, therapeutic devices, and laboratory equipment
Medical Devices – Regulatory guidance and services including licensing, registration, compliance, and post-market surveillance.
Foodstuffs – Fortified foods, nutraceuticals, and supplements
Foodstuffs – Regulatory guidance and services including product formulation and product compliance.
Cosmetics – Skincare, haircare, and personal care products.
Cosmetics – Regulatory guidance and services including, product formulations, and product compliance.
Unregistered medicines
We support with regulatory guidance and regulatory services for unregistered medicines for rare diseases/conditions, investigational drugs, or foreign-approved products that are not yet registered with local NRAs.
We support with transition to full registration: Section 21 medicines may apply for full market registration after local research studies or after meeting SAHPRA's regulatory requirements
Regulatory guidance, support and sourcing for section 21 medicines
Services
Licensing, certification, regulatory compliance and adherence services
Product development and product formulation
Electronic Common Technical Document (eCTD) Dossier preparation and compilation
Electronic Common Technical Document (eCTD) Dossier submissions
Product life cycle management
Pharmacovigilance and post marketing surveillance
Variation Applications – Submission and management of product variations with NRAs
Product Information (PI) Compilation & Translation – Preparation, translation, and submission of PIs.
Patient Information Leaflet (PIL) Compilation & Translation – Preparation, translation, and submission of PILs
Artwork – Regulatory review of packaging and labelling
NAPPI Code Applications – Application and registration of NAPPI codes for section 21 medicines SAHPRA
Support for registration, market authorization, and licensing of healthcare products, fully aligned with National Regulatory Authority's (NRA's) regulations.