The Makromed branch in Azerbaijan is based in Baku and supports drug, medical device and food-supplement registration, regulatory affairs and pharmacovigilance.

Medicines and medical device registration in Azerbaijan

The Baku office prepares registration dossiers, reviews documentation gaps and handles correspondence with the competent authorities. Technical files for medicines, medical devices and food supplements are organised in CTD and ACTD format, translated and adapted to local requirements.

• National registration and renewal of medicinal products
• Documentation for medical devices and food supplements
• Distributor search and local partnerships
• Follow-up of post-registration variations

Pharmacovigilance and GxP compliance

The branch helps set up pharmacovigilance systems, collect adverse-event information and prepare for GxP audits. The aim is to keep products safe on the Azerbaijani market and maintain ongoing compliance between the manufacturer and local legislation.

Since 2013 the Baku office has been the centre of Makromed’s regional network, working to the same quality standard as the branches in India, Uzbekistan, Georgia and Russia.