Pharmaceutical Regulatory Services | Drug Registration Iraq

What We Offer

Regulatory & Compliance Services

We support local and international companies in navigating regulatory pathways, market access, and post-marketing requirements across Iraq and the Middle East.

Regulatory Affairs

We manage regulatory pathways for pharmaceuticals, biotechnology products, and medical technologies. Our work covers submission preparation, authority communication, lifecycle changes, and ongoing compliance to support successful market entry and maintenance within Iraq and the region.

Product registration and market authorization
Dossier preparation and review (CTD/eCTD)
Audit compliance and submission follow-up
Laboratory testing and material readiness coordination
Lifecycle and post-approval management
Labeling and artwork review

Pharmacovigilance

We provide end-to-end support for safety monitoring and risk management activities in line with local and international requirements. We support companies through local safety representation, system setup, documentation oversight, and team training to ensure continuity and regulatory readiness.

Local safety oversight and representation
Pharmacovigilance system setup and management
Adverse event case processing and reporting
Periodic safety reports (PSUR/PBRER)
Risk management plans (RMP)
Safety training and team development

Regulatory Consultation

We support companies during key regulatory decision points, including pricing discussions, authority interactions, and strategic planning. We help organizations assess regulatory pathways, identify potential challenges early, and prepare clear, management-ready recommendations before critical submissions or market decisions.

Pricing and authority engagement support
Market entry feasibility assessment
Regulatory gap analysis
Compliance audits and remediation
Regulatory liaison with health authorities
Strategic advisory for product lifecycle

Quality Systems & Compliance

We assist life sciences companies in building and maintaining structured quality frameworks aligned with recognized international standards. Our services include system design, readiness preparation, internal assessments, and guidance toward certification through accredited partners.

Quality management system (QMS) design
GMP and GDP implementation
Internal auditing and readiness assessments
CAPA management
Standard operating procedure (SOP) development
Guidance toward certification and accreditation

Clinical Research Support

We provide support across clinical research activities for pharmaceutical, biotechnology, and medical technology companies. Our involvement spans early feasibility assessments, regulatory coordination, study oversight, and compliant documentation.

Clinical trial regulatory submissions
Early feasibility assessments
Ethics committee application support
GCP compliance guidance
Study oversight and coordination
Medical writing and documentation

Authorized Local Representative

PKCS acts as your authorized local representative for regulatory and compliance matters with Iraqi health authorities. We provide coordinated support that helps organizations manage regulatory requirements efficiently while maintaining local compliance.

Local authorized representation with Iraqi MOH
Regulatory submission and follow-up on your behalf
Authority communication and liaison
Gap analysis and drafted letters
Translation and design coordination
MOH submission and file compilation

Ready to Navigate the Iraqi Regulatory Landscape?

Partner with PKCS for expert guidance on regulatory compliance, market access, and quality assurance across the Middle East.

Our Services