Medicine and Medical Device Registration and Early Market Access

Umsebe Healthcare, provides expert regulatory services in the areas of medicine and medical device registration and regulatory market access strategy to enable the quickest regulatory route to market, via a sound, robust scientific basis for registration and a quality assured submission dossier, ensuring the quickest turn-around time to successful product approval.

KD Consulting Pharmaceutical Solutions is a sister company to Umsebe Healthcare and is a leading specialised pharmaceutical consulting practice delivering regulatory affairs, quality assurance, risk management, pharmacovigilance, and compliance services and solutions through a robust scientific approach, backed by over a decade of consulting practice experience in Africa and by professional service delivery.

During the product licensing phase, Umsebe is able to offer healthcare professionals and patients with unmet medical needs early access to treatment via Named Patient Access. Umsebe holds a notable reputation for successful Section 21 (named patient access) permit approval for access to un-licensed medicines.