Regulatory Affairs
DAWANA provides comprehensive regulatory support to help healthcare companies navigate the Iraqi market with confidence.
Regulatory Affairs
Regulatory Affairs
Our team coordinates product-registration activities, regulatory documentation, authority communications, and post-approval requirements to support timely, compliant, and sustainable market access.
Working closely with our partners, we help align international product dossiers with local regulatory requirements while maintaining accuracy, transparency, and close follow-up throughout the registration process.
Our support extends beyond initial approval to include renewals, variations, labeling updates, artwork review, and ongoing regulatory maintenance.
Key capabilities
- Regulatory pathway assessment and planning
- Product-registration coordination
- Dossier review and document-gap analysis
- Communication and follow-up with relevant authorities
- Labeling, packaging, and artwork compliance review
- Registration renewals and product variations
- Post-approval regulatory maintenance
- Regulatory intelligence and requirement monitoring
- Coordination with quality, supply-chain, medical, and commercial teams