Regulatory Affairs
We provide comprehensive regulatory services, including the evaluation and submission of documentation and timelines for product registration in compliance with the UAE Ministry of Health and Prevention (MOHAP). Our experienced regulatory team works closely with our partner’s regulatory department to ensure all mandatory registration criteria are met. Our services include:
- Registration of Marketing Authorization Holders
- Registration of Manufacturing Sites
- Registration of Medicinal Products, such as:
- Conventional products
- Biological products
- Over-the-Counter (OTC) products
- Registration of Natural Medicines (Herbal and Homeopathic products)
- Registration of Medical Devices, including AI-powered software
- Registration of Cosmetics, Health Supplements, Food Products, and Antiseptic Products with Dubai Municipality
- Medical Store Endorsement Applications, facilitating product transfers to Epione Drug Store.
Epione also ensures the inclusion of new molecules in the Dubai Drug Code (DDC), Health Authority Abu Dhabi (HAAD), and insurance lists. Once approved for insurance coverage, products can be prescribed by doctors in public and private hospitals through insurance. This enables our marketing team to initiate promotional activities based on the strategies of our partners.
Our Partners
