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 place emphasis on training and on-going development […]

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Registration & Life-cycle News

eCTD has been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products. Significant changes have been implemented for the administrative particulars for the ZA eCTD. The introduction of several new template documents and guidelines requires considerably more regulatory work to go into the creation of registration applications

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