BURAN / REGULATORY AFFAIRS

Registration Support for Iraq

Document preparation and coordination for pharmaceutical manufacturers and product portfolios.

Prepare the Right File from the Start

Buran’s regulatory and quality functions form part of its coordinated service approach. Manufacturer and product registration involve distinct document sets, and the applicable route should be established before preparing a submission.

Our registration resources organise the supplied reference requirements into practical starting points for a discussion with the regulatory team.

Registration Fees

Reference amounts from the supplied schedule, to be reconfirmed for the actual application.

View Fee Reference →

How to Start

  1. Introduce the manufacturer. Share the company profile, country of origin and manufacturing-site information.
  2. Identify the product category. Provide dosage forms, product lists and existing registration status.
  3. Review the available documents. Include GMP or quality certificates, manufacturing licences and CPP or free-sale certificates where relevant.
  4. Agree the preparation scope. Clarify document gaps, certification needs and the appropriate application route.

Different Categories, Different Requirements

The supplied manufacturing-registration materials cover pharmaceuticals, dietary supplements and plant-based medicines, medical supplies, laboratory materials and medical or laboratory devices. Quality certificates and forms differ between categories; a pharmaceutical checklist should not be applied unchanged to a device or supplement dossier.

Let’s Plan the Next Step.

Contact Buran to discuss your manufacturer, portfolio and requirements in Iraq.

Discuss Registration Support →

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