Contact Details:

Tel:  +27 44 877 1550
Fax:  +27 86 766 3481
+27 82 822 5109


Draft regulations for registration of medical devices in South Africa
The South African regulatory authority has revised regulations relating to the registration of medical devices in the country. The draft regulations which were released for comment will significantly change the registration process in the country with a more comprehensive dossier being required for the process. The comment period has now closed. Please see the attached file here.

Complementary and Alternative Medicines Registration in South Africa - Request for review of regulations from industry group
The release in November 2013 of the regulations for registration of Complementary and Alternative Medicines in South Africa has resulted in much debate in the industry. Representations have been made by various groups within the industry to the Medicines Control Council for clarification for amendments to the regulations, a copy of which can be accessed here . Comments can be forwarded to the discussion group directly - details can be found on page 14 of the document.

17th World congress of Basic and Clinical Pharmacology in Cape Town
The Congress will be held from 13-18 July 2014 in Cape Town, South Africa. There is an excellent scientific programme as well as a variety of pre- and post-congress satellite meetings. The Congress will be opened by Nobel Laureate for Chemistry 2012, Dr. Robert Lefkowitz, Professor at Duke University Medical Center, brings together some of the world's leading pharmacologists and is a unique networking opportunity. More information can be found in the attached link or at

FDA: Draft Guidelines for clinical pharmacology data to support biosimilarity
On 9 May 2014, the FDA released for comment a draft guidance for clinical pharmacology data required to demonstrate biosimilarity to a reference product. The Guidance expands on the 2012 document and should provide drug developers a more structured roadmap in the development of biosimilars. The guidance can be accessed here .

And now for something completely different…
Anyone who knows me knows that I'm fascinated by the cosmos and anything that relates to it….. have a look at the YouTube item by Neil deGrasse Tyson on Can fish swim in space? Enjoy Star Trek Radio!

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Regulatory Services:

Regulatory services are offered for South Africa and most of English speaking countries in Africa.

Provision of consulting services to the pharmaceutical industry for the following are available:

  • Regulatory and Ethics Committee submissions for clinical trials with biological agents and small chemical molecules, medical devices and complimentary medicines including but not limited to Phase I, II and III, Proof of concept, First-in-Man, SAD (single ascending dose) and MAD (multiple ascending dose) Phase I studies.
  • Guidance on regulatory strategies in particular for Phase I / Early phase trials with respect to clinical trial design especially for early phase research review of protocols and study related documents for studies.
  • Compilation / assessment of applications for regulatory approval of clinical trials (all Phases of research)
  • Preparation of periodic progress reports for health authorities and ethics committees.
  • Regulatory project management to complement in-house regulatory departments in areas such as
    • preparation of major submissions
    • development, review and/or updating of Standard Operating Procedures (SOPs)

Back-up services provided: DRConsulting will step in and take over regulatory responsibilities for an ongoing project should you need back-up service during a scheduled or unexpected leave of absence of one of your key staff members.

As an independent consultant/contractor and depending on size and scope of your project, DRConsulting will manage your project either independently or working closely with your regulatory affairs team. 


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