Downloadable Resources

Access our collection of regulatory guides, compliance templates, and industry resources to support your operations.

Iraqi Regulatory Landscape Overview

A summary of the pharmaceutical regulatory framework in Iraq, including key authorities, registration pathways, and compliance expectations for local and international companies.

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Pharmacovigilance System Setup Guide

A practical reference for establishing a pharmacovigilance system, covering PSMF structure, adverse event reporting workflows, and periodic safety update report requirements.

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GMP Compliance Readiness Checklist

A structured checklist for pharmaceutical manufacturers and distributors to assess their GMP and GDP compliance status, identify gaps, and prepare for audits.

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Regulatory FAQ for Iraq

Answers to frequently asked questions about pharmaceutical registration, pricing, labeling, and post-marketing requirements in Iraq and the Middle East.

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Clinical Trial Requirements Guide

A reference guide for companies planning clinical research in Iraq, covering regulatory submissions, ethics committee applications, GCP requirements, and documentation standards.

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Quality System Documentation Templates

Template references for SOPs, quality manuals, CAPA forms, deviation reports, and other quality management documentation used in pharmaceutical operations.

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These resources are available to pharmaceutical, biotechnology, and medical device companies working with PKCS. Contact us to request access or discuss your specific needs.

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