Author Archives: Henriette Vienings

Our Compliance Webinar Series for 2020 caters for a wide range of portfolios in weekly intervals. The webinars are live and provide for Q&A interaction – Compliance Webinar Schedule – 2020 Training in relation to the compliance requirements and Good Practice (GxP) expectations for healthcare products, is offered for: Company Executives & Board Members (Pharmaco-) Vigilance Officers GxP… Continue Reading

Training & Mentoring We provide project based mentoring for regulatory personnel and bespoke training for your regulatory affairs team. Training in compliance requirements related to current Good Practice (cGxP) expectations for healthcare products is also offered for: Company Executives & Board Members (Pharmaco)Vigilance Officers GxP for Applicants / Holders of Certificates of Registration Regulatory Documents | Authoring… Continue Reading

eCTD/eSubmissions As of 1 August 2019 the South African Health Products Regulatory Authority (SAHPRA) only accepts electronic submissions for applications for registration of Biological and Pharmaceutical Health Products. The SAHPRA website contains all the forms and guidance documents related to the ZA eCTD specifications and content requirements. Let us help you publish your eCTD – contact info@mra-regulatory.com. Continue Reading

Changes to the Medicines and Related Substances Act The Medicines and Related Substances Act was amended on the 22nd of May 2017 by the promulgation of the Act 72 of 2008 and Act 14 of 2015 – the Medicines and Related Substances Amendment Acts. These changes to the legislation gave rise to the South African… Continue Reading

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