Regulatory Affairs & Pharmacovigilance

Regulatory Affairs & Pharmacovigilance Department

Our Regulatory Department takes of the regulatory affairs and pharmacovigilance activities. We are responsible for all submissions to the UAE health authorities, such as MOHAP, DHA, DOH, and Dubai Municipality. This includes new drug registration, manufacturing site, and company registration, renewals, minor variation, and DDC / DOH Coding registration.

We have a broad experience in the registration of all product classes including Conventional/Biological Medicines, Medical Devices, Herbal products, Dietary Supplements, and more.

  • Conventional Medicines

  • Biological Medicines

  • Medical Devices

  • Herbal Products

  • Dietary Supplements

Our RA&PV Team works closely with health regulators with a full understanding of the time to market value to our principle companies

International compliance guidelines

Local regulations & guidelines

Pharmacovigilance activities & processes

QA & Product Technical complaint handling

Our team acts as a liaison between principal companies & the regulatory bodies in the country

Principles

pharmaworld

Regulatory bodies