Madelein Terblanche is a seasoned regulatory affairs and digital transformation expert specializing in eCTD and eSubmission implementation. With extensive experience in training, consulting, and regulatory harmonization, Madelein has played a pivotal role in supporting agencies like SAHPRA and ANMPS in adopting streamlined electronic submission processes.

As a key contributor to eCTD specification authoring, Madelein has developed industry guidelines and validation criteria, ensuring compliance with global best practices. Her expertise extends to document and submission management configuration, optimizing workflows for regulatory agencies and the pharmaceutical industry.

In addition to regulatory consultancy, Madelein is a skilled project manager, successfully leading major initiatives such as national regulatory authority implementations, docuBridge system rollouts, and industry workshops. Her commitment to knowledge-sharing is evident in her role as a speaker and moderator at international conferences, including LORENZ Converge, AfriSummit, and SAAPI.

Passionate about regulatory harmonization in Africa, Madelein actively contributes to the advancement of eCTD adoption across the continent. Her ability to bridge technical expertise with strategic policy development makes her a leading voice in the field of digital regulatory transformation