Knowledge Hub
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.
Request AccessPharmacovigilance System Setup Guide
A practical reference for establishing a pharmacovigilance system, covering PSMF structure, adverse event reporting workflows, and periodic safety update report requirements.
Request AccessGMP 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.
Request AccessRegulatory FAQ for Iraq
Answers to frequently asked questions about pharmaceutical registration, pricing, labeling, and post-marketing requirements in Iraq and the Middle East.
Request AccessClinical Trial Requirements Guide
A reference guide for companies planning clinical research in Iraq, covering regulatory submissions, ethics committee applications, GCP requirements, and documentation standards.
Request AccessQuality System Documentation Templates
Template references for SOPs, quality manuals, CAPA forms, deviation reports, and other quality management documentation used in pharmaceutical operations.
Request AccessThese resources are available to pharmaceutical, biotechnology, and medical device companies working with PKCS. Contact us to request access or discuss your specific needs.
