Our Key Regulatory Services Include:
✅ Regulatory Strategy Development
We build customized regulatory roadmaps to support your product’s journey from concept to commercialization, ensuring minimal delays and optimized approval timelines.
✅ Dossier Compilation & Submission
We prepare and submit high-quality regulatory dossiers (CTD/eCTD) for:
New Drug Applications (NDAs)
Marketing Authorization Applications (MAAs)
Generic Submissions
Over-the-Counter (OTC) Products
Biologicals & Biosimilars
✅ Product Registration
We manage end-to-end product registration processes across the UAE, GCC, and international markets, ensuring local compliance and timely approvals.
✅ Regulatory Liaison
Our team coordinates directly with health authorities such as:
UAE Ministry of Health and Prevention (MOHAP)
GCC Drug Regulatory Authorities
EMA, FDA, and other global regulatory bodies
✅ Labeling & Artwork Compliance
We ensure your product labels, leaflets, and packaging meet regulatory requirements and are up to date with current guidelines.
✅ Post-Marketing Surveillance & Variations
From handling safety updates to managing variations and renewals, we support the long-term regulatory maintenance of your pharmaceutical products
