ServicesRegulatory Consultancy

Comprehensive Regulatory Support for Healthcare Products in the UAE.

At TRIOUS, we specialize in providing end-to-end regulatory support to companies seeking to register a wide range of healthcare products in the United Arab Emirates (UAE). With our extensive experience and in-depth knowledge of local regulations, we streamline the registration process for pharmaceuticals, medical devices, cosmetics, personal care products, and supplements, ensuring compliance with all relevant authorities.

Navigating the regulatory landscape can be complex, especially in a dynamic market like the UAE. Our team of experts is well-versed in the intricacies of regulatory requirements and is dedicated to guiding our clients through every step of the registration process.

1. Pharmaceuticals: Registering pharmaceutical products in the UAE requires meticulous attention to detail and adherence to strict regulations set forth by the Ministry of Health and Prevention (MOHAP). Our regulatory specialists work closely with clients to compile all necessary documentation, including product dossiers, manufacturing licenses, and quality certificates, to facilitate smooth registration and market entry.
2. Medical Devices: The registration of medical devices in the UAE involves compliance with regulations issued by the Emirates Authority for Standardization and Metrology (ESMA). Our team ensures that all medical devices meet the requisite safety and performance standards, helping clients navigate the registration process efficiently and effectively.
3. Cosmetics and Personal Care Products: The UAE market for cosmetics and personal care products is highly regulated, with requirements set by the Emirates Conformity Assessment Scheme (ECAS). We assist companies in preparing comprehensive product dossiers, including safety assessments and ingredient lists, to facilitate timely registration and market approval.
4. Supplements: Registering dietary supplements and health products in the UAE requires compliance with regulations established by the Emirates Authority for Standardization and Metrology (ESMA). Our regulatory experts provide guidance on labeling requirements, ingredient specifications, and safety assessments to ensure successful registration and market entry.

Regulatory Services in UAE provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We collaborate with experts to facilitate effortless delivery of product launches, regulatory filing, and market authorizations.

Our services include but are not limited to the following:

• Regulatory Strategies and Expert Views
• Regulatory Due Diligence
• Gap Analysis and Remediation
• Post Approval Life Cycle Management
• API sourcing
• Risk Management
• Aggregate Reports
• Signal Management
• QPPV Services
• Bio Waiver Justifications
• Clinical & Non-Clinical Experts Reports
• RLD sourcing and supply
• GMP audits
• Bioequivalence study monitoring & auditing service

Our approach to regulatory support is tailored to the specific needs of each client, taking into account the unique characteristics of their products and target market. We offer comprehensive services that encompass regulatory strategy development, document preparation, submission management, and ongoing compliance monitoring.

At TRIOUS, we understand the importance of speed to market and strive to expedite the registration process without compromising on quality or compliance. Our proactive approach and attention to detail enable us to anticipate potential challenges and address them proactively, minimizing delays and ensuring timely market access for our clients.