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Regulatory & Registration Consulting

End-to-end regulatory support for successful product registration and market entry in Iraq.

We act as your local regulatory representative preparing dossiers, submitting registrations, managing renewals.

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About this service

Danafarma provides comprehensive regulatory support to international manufacturers seeking to register, introduce, and maintain healthcare products in the Iraqi market. Our regulatory team coordinates documentation, product registration, artwork requirements, regulatory submissions, and communication with the relevant health authorities throughout the registration process.

Navigating regulatory requirements is a critical part of successful market entry. Our team works closely with manufacturing partners from the initial assessment of a product and its documentation through dossier preparation, submission, authority follow-up, and final registration.

We also provide ongoing regulatory support after registration, including renewals, variations, artwork and labeling updates, import-related documentation, and coordination of regulatory changes. By combining regulatory expertise with our commercial and distribution capabilities, Danafarma provides partners with an integrated route from product registration to market launch and nationwide distribution in Iraq.

KMCA Registration Support Submission & follow-up
Iraqi Health Authority Coordination Dossier preparation
Product Registration & Renewals Renewals & variations

How it works

  1. 1

    Assess requirements

    We assess the product classification, regulatory pathway, documentation requirements, and applicable health-authority procedures.

  2. 2

    Prepare & submit

    We prepare, review, and submit the complete registration dossier to the relevant regulatory authorities In Iraq and Kurdistan region.

  3. 3

    Manage approvals & compliance

    We follow up on applications, respond to authority requirements, and manage renewals, variations, and post-market obligations.

Frequently asked

Can you represent international manufacturers?
Yes. We can act as the local authorized representative and regulatory partner for international manufacturers seeking product registration, market entry, and ongoing compliance in Iraq.
How long does registration take?
Registration timelines vary depending on the product category, documentation, and the relevant regulatory authority. We assess the requirements in advance and provide a clear regulatory pathway and estimated timeline.

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