Pharmaceutical Medicine Registration and Compliance

Let us assist you to register your medicines or medical Devices in South Africa.

The registration of medicines and medical devices and IVDs in South Africa is governed by the provisions and  requirements of the Medicines and Related Substances Control Act No. 101 of 1965,

All Medicines Sold in South Africa has to be registered before commercialisation. Medical Devices follow another regulatory pathway and is dependent on CE certification and other requirements for classification.

Successful track History

Choosing a regulatory partner is only Step 1.  Having the products commercialised is the Ultimate step.

Educated & Experienced Team

We have a well nit network of professionals that can assist you in listing and making your product available to patients, healthcare providers and consumers at large.

Modern Business Solutions

Allow us to in or out-license your dossiers in South Africa and Southern Africa.

Inspection & Accreditation

If you have a manufacturing facility in other countries, we can assist you in getting your facility registered and accredited to supply products into South Africa, provided that you fallow the stringent GMP guidelines of highly regulated markets.

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Approval of Unregistered Medicines for Compassionate use

The South African Health Products Regulatory Authority, known as SAHPRA, allows for  for compassionate use of the economical and much needed medicines. In particular medicines for Rare and Orphan Diseases. The regulatory authority still warrants clinical data before it can issue any formal approval  via the legal framework of section 21 of the Medicines and Related Substances Control Act in South Africa. In this way, physicians can secure access and prescribe much needed medicines provided that  the results can be tracked in near real time for a source of real world data.
  • Registration of Complimentary Health Products and Supplements
  • Classification and review of products
  • Preparation of Dossiers for submission of registered medicines
  • Customisation of your dossier for submission into South Africa and neighbouring countries.
  • Submission and Registration in South Africa with SAPRA
  • Market Development of Niche products for commercialisation
  • Retail of products through our sales teams and networks
  • Maintenance of the product through its lifecycle.