Our Services
Discover our comprehensive range of regulatory affairs services for pharmaceutical, medical device, and cosmetics sectors in Iraq. We provide expert solutions for KMCA and MOH Baghdad compliance.
Product Registration
We provide comprehensive regulatory submissions and approvals for pharmaceutical, medical device, and cosmetic products. Our expertise covers both KMCA and MOH Baghdad processes, ensuring efficient and compliant product registrations for Iraqi market entry.
Our services at a glance:
- •KMCA product registration and renewals
- •MOH Baghdad regulatory submissions
- •Medical device registration
- •Cosmetic product approvals
- •Pharmaceutical product registrations
- •Company registration and licensing
- •Marketing authorization holder (MAH) services
- •Regulatory strategy development
Regulatory Compliance
Our compliance services ensure adherence to local and international regulatory standards. We provide guidance on WHO, GMP, FDA, MHRA, and PICS requirements while maintaining compliance with KMCA and MOH Baghdad regulations.
Our services at a glance:
- •WHO compliance guidance
- •GMP certification support
- •FDA regulatory alignment
- •MHRA standards compliance
- •PICS guidelines implementation
- •Quality management systems
- •Regulatory audits and inspections
- •Compliance gap analysis
Legal Translation
We offer professional multilingual regulatory documentation services in Arabic, Kurdish, and English. Our certified translators ensure accurate and compliant translation of all regulatory documents, technical files, and legal documentation.
Our services at a glance:
- •Arabic regulatory document translation
- •Kurdish technical documentation
- •English compliance materials
- •Certified legal translations
- •Technical file translations
- •Labeling and packaging compliance
- •Regulatory correspondence translation
- •Multi-language document management
Training & Consulting
We provide comprehensive regulatory training programs, webinars, and custom consulting services for suppliers and distributors. Our educational services help build internal regulatory capabilities and ensure ongoing compliance.
Our services at a glance:
- •Regulatory affairs training programs
- •KMCA and MOH submission workshops
- •International standards webinars
- •Custom regulatory consulting
- •Distributor training sessions
- •Compliance team development
- •Regulatory strategy consulting
- •Market access guidance
Post-Market Surveillance
Our post-market surveillance services ensure ongoing compliance and monitoring of registered products. We provide CAPA report preparation, regulatory tracking, and continuous compliance monitoring for sustained market presence.
Our services at a glance:
- •Post-market surveillance programs
- •CAPA report preparation and guidance
- •Regulatory tracking systems
- •Compliance monitoring services
- •Regulatory alerts and updates
- •Government authority liaison
- •Adverse event reporting
- •Product lifecycle management
Our Work Process
From the first consultation to the finished project – this is how we work transparently and reliably for your success.
Consultation
In the first step, we conduct a detailed consultation to understand your requirements and wishes.
Planning & Concept
Based on your requirements, we develop a tailor-made concept for your project.
Offer & Contract
You will receive a detailed offer with transparent cost breakdown and clear service descriptions.
Implementation
Our professionals implement the project on schedule and with the highest quality.
Acceptance & Instruction
After completion, we conduct a joint acceptance and provide thorough instruction for the new system.
Service & Maintenance
We offer you long-term service and regular maintenance for optimal functionality of your system.
Frequently Asked Questions
Here you will find answers to the most common questions about our regulatory affairs services. If you have further questions, please feel free to contact us.