Services
Regulatory lifecycle
Registration is the start, not the end. We keep your products compliant with the MOH and the KMCA for as long as they are on the market.
An extension of your regulatory team
Requirements in Iraq change, and both authorities expect registered products to keep pace. A missed renewal or an unapproved label change can stop a shipment at the border.
We track every registration we hold for you, tell you in advance when action is needed and handle the filings with your regulatory affairs team, so your products stay on the market without surprises.
What we look after
Dossier review before submission
A pre-submission audit of your CTD or eCTD dossier. We find and fix the deficiencies that most often lead to committee rejections, before the file leaves your hands.
Variations and renewals
Type IA, IB and II variations for changes to specifications, manufacturing sites or labelling, managed so that supply to the market is not interrupted.
Labelling and Arabic translation
Outer cartons, patient information leaflets and SmPCs checked and translated to meet Iraqi language and layout requirements.
Pharmacovigilance and post-marketing
Guidance on adverse event reporting, post-marketing surveillance and local Good Distribution Practice requirements throughout the product's life.