Services South Africa

Clinical trials – Regulatory –  Quality Systems

Clinical trials

South Africa is an ideal location for clinical trials due to its diverse population and research infrastructure.

  • Human clinical trials with pharmaceuticals or medical devices

We take care of the study setup, management, and compliance with international standards.

This includes also import and logistics of the investigational medicinal product (or medical device)

For veterinary clinical trials – see Services « Veterinary Medicine »


Regulatory advice & operational

  • Regulatory compliance, agency consultation
  • Marketing authorisation submissions at the South African Health Products Regulatory Authority (SAHPRA)


Quality systems

We set up your QMS or find a partner to distribute your products in South Africa

Medicinal products : Pharmaceutical QMS in South Africa follow PIC/s

Medical devices: Implement ISO 13485 QMS locally in South Africa


Company establishment South Africa

Support in company set up in South Africa

Pharmaceutical or medical device

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