Product Registration & Licensing
Accelerate your product’s market entry with expert registration and licensing support.
"Trust ITROM to navigate complex regulations with ease."
What We Offer
Bringing pharmaceutical products to new markets requires careful navigation of regulatory landscapes.
At ITROM, our Product Registration & Licensing service ensures your medical and pharmaceutical products meet all necessary legal and regulatory requirements — efficiently and accurately.
What’s Included in This Service?
Regulatory Dossier Preparation
Complete and compliant documentation for submission.
Local Regulatory Submissions
Submission and management of applications across MENA countries.
Authority Liaison
Direct communication and coordination with health ministries and regulatory bodies.
Product Classification & Compliance Check
Ensure products are correctly classified and meet standards.
License Maintenance
Support for license renewals, amendments, and post-market changes.
Strategic Regulatory Consulting
Guidance to avoid delays and increase approval success rates.
Why It Matters
Proper registration and licensing help you:
- Legally sell your products in target markets
- Avoid costly delays, fines, and compliance issues
- Gain trust with healthcare providers and patients
- Ensure product safety and quality standards are met
Our Regional Expertise
- Deep understanding of regulatory environments in UAE, Saudi Arabia, Egypt, and beyond
- Strong working relationships with health authorities across MENA
- Experience with a wide range of pharmaceuticals, biologics, and medical devices