We provide project-based mentoring for regulatory departments and bespoke training for your regulatory affairs team. New CPD requirements have been published by the South Africa Pharmacy Council and as of January 2020 there is a set expectation for compliance thereto. The GxP requirements in terms of the Medicines Act and also place emphasis on training and …

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Registration & Life-cycle News

eCTD / eSubmissions have been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products, starting 1 August 2019.Significant changes have been implemented for the ZA regional content for eCTD/eSubmissions. The introduction of several new template documents and guidelines requires considerably more regulatory work to go into the …

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Nationwide Lockdown

During this time of unprecedented disruption to all levels of society, we wish you all the very best, health and fortitude. We would like to advise you that MRA will continue to serve during the shut-down period. We are working from home and will be available via the normal contact routes – phones & emails. …

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