About Us
Since 2024, Aflanova Regulatory Affairs Agency has been a specialized consultancy firm offering end-to-end regulatory affairs services to the pharmaceutical, medical device, and cosmetics sectors operating in Iraq.
We are uniquely positioned to navigate the complex regulatory environments of both the Ministry of Health (MOH) – Baghdad and the Kurdistan Medical Control Agency (KMCA). We act as a regulatory bridge between international pharmaceutical manufacturers and Iraqi market distributors and stakeholders, helping our clients comply with all legal and procedural requirements for product registration, market entry, and post-approval maintenance.
35+
Years of Experience
1000+
Successful Registrations
25+
Partner Distributors
Our History
Learn more about the development of Aflanova from inception to becoming Iraq's leading regulatory affairs consultancy.
Aflanova Founded
Aflanova Regulatory Affairs Agency was established with the vision of becoming a trusted regulatory affairs consultancy serving Iraq and the broader Middle East.
KMCA & MOH Partnerships
Established strategic partnerships with Kurdistan Medical Control Agency (KMCA) and Ministry of Health (MOH) Baghdad to facilitate regulatory processes.
International Client Base
Successfully onboarded major pharmaceutical distributors including Dlbeen Group (37 suppliers), Power Pharma (9 suppliers), and Kawkab Group (18 suppliers).
Service Expansion
Expanded services to include legal translation, customs consulting, training programs, and comprehensive regulatory tracking systems.
Leading Regulatory Partner
Recognized as the leading regulatory affairs partner in Kurdistan region and Iraq, providing expert solutions for pharmaceutical compliance and market access.
Our Values
These principles guide our daily actions and shape our collaboration with customers and partners.
Integrity
Upholding the highest standards of honesty, ethics, and regulatory compliance in all our interactions.
Professionalism
Ensuring accuracy, attention to detail, and expertise in every document and regulatory interaction.
Accountability
Taking full responsibility for our commitments and results, ensuring client success in regulatory processes.
Confidentiality
Respecting and safeguarding sensitive information with the highest level of data protection and privacy.
Global Standards
Delivering world-class service aligned with international regulatory frameworks including WHO, GMP, FDA, and MHRA.
Reliability & Partnerships
Establishing lasting relationships based on trust, consistency, and long-term collaborative success.
Vision, Mission & Expertise
Learn about our commitment to excellence in regulatory affairs and our strategic position in the Iraqi pharmaceutical market.
Our Vision
To be the leading regulatory affairs partner in the Kurdistan region and Iraq, driving excellence in pharmaceutical compliance, ensuring timely product registrations, and fostering a healthier future through seamless collaboration with health authorities and pharmaceutical companies.
Our Mission
We provide expert regulatory solutions to support pharmaceutical companies in navigating complex registration at KMCA and MOH Baghdad. Our commitment lies in ensuring compliance with both local and international standards, promoting public health through safe, effective products, and fostering strong collaborations with authorities and industry leaders. Guided by innovation, integrity, and professionalism, we connect regulatory demands with successful market access.
Key Expertise
Deep knowledge of KMCA and MOH regulations, international compliance standards (WHO, GMP, FDA, MHRA, PICS), multilingual regulatory documentation, and established partnerships with local & international pharmaceutical firms across Iraq and Kurdistan region.
Our Presence
Main Office: Erbil, Kurdistan. Coverage: Kurdistan Region & Baghdad. Collaborations: Partnerships with major distributors including Dlbeen Group (37 suppliers), Power Pharma (9 suppliers), Kawkab Group (18 suppliers), and Sarinaz Company (8 suppliers).