Regulatory Services

Regulatory Submissions & Market Access

We facilitate regulatory submissions and market access in the UAE, ensuring full compliance with Ministry of Health and Prevention (MOHAP) standards. Our services encompass product registration, dossier preparation, and seamless submission processes, supporting a smooth path to market for healthcare products.

Product Approval & Facility Licensing

Achieving product approval and facility licensing in the UAE is essential for market entry and regulatory compliance. We guide businesses through the Ministry of Health and Prevention (MOHAP) requirements, covering all stages from product evaluation and registration to facility inspection and licensing. Our support includes documentation preparation, submission management, and liaising with authorities to ensure timely approvals and adherence to regulatory standards. By streamlining these processes, we help clients launch products and establish facilities with confidence in the UAE healthcare market.

Pre-Submission Gap Analysis

Our Pre-Submission Gap Analysis service proactively identifies compliance gaps to enhance regulatory submission success in the UAE. We thoroughly evaluate product documentation, technical specifications, and labeling to ensure full alignment with MOHAP standards. By addressing potential issues before submission, we help clients optimize their regulatory packages, avoid delays, and increase their chances of achieving a smooth and timely approval.

Technical Writing for Regulatory Submissions

Our Technical Writing services support regulatory submissions by creating clear, accurate, and compliant documentation tailored to UAE regulatory standards. We develop and refine dossiers, product descriptions, labelling, and technical summaries in line with MOHAP requirements. Our expertise ensures high-quality submissions, reducing the likelihood of delays and improving the chances of approval, helping clients efficiently navigate the regulatory landscape in the UAE.

Regulatory Knowledge Hub

Our Regulatory Knowledge Hub is a comprehensive resource for navigating UAE regulatory requirements. It offers the latest updates, guidance documents, and insights on MOHAP standards to support businesses in submission preparation, compliance, and market entry. With trusted, up-to-date information, our Knowledge Hub helps streamline regulatory processes in the UAE.

Product Compliance Labeling

Our Product Compliance Labeling services ensure that product labels meet all regulatory requirements for accuracy, clarity, and compliance in your target market. We support businesses with label content review, formatting, language translation, and alignment with local regulatory standards to avoid delays and ensure approval. With our expertise, clients can confidently bring compliant products to market, meeting consumer expectations and regulatory demands.