Turning Innovation into Reality
Our registration services are designed to ensure that your groundbreaking products meet all regulatory requirements, paving the way for their success in the market. We handle every aspect of registration with meticulous care, so you can focus on what you do best innovating.
- New Drug Registrations: Human Drugs, Biologics, Biosimilars, Herbals, Health Products, Cosmetics, and Food Supplements. We guide your products through the complex regulatory landscape, ensuring they reach consumers swiftly and safely.
- New Medical Device Registration (MDMA): From advanced medical devices to essential health tools, our registration services guarantee compliance with global standards.
- Authorized Representative (AR): We act as your authorized representative, ensuring your products meet the necessary legal and regulatory requirements in every market.
- Unique Device Identifier (UDI): Streamlining product identification with globally recognized standards, ensuring traceability and compliance.
- Technical File Development: Comprehensive technical documentation tailored to meet regulatory standards.
- ISO 13485 Compliance: Achieving and maintaining the highest standards in medical device quality management systems.
- Life Cycle Management: Handling variations, renewals, updates, and more, ensuring your products remain compliant throughout their lifecycle.
- Product Classification: Navigating the complexities of product categorization to ensure accurate and efficient registration.
- Arabic Design of Labeling Information: Crafting culturally sensitive and regulatory-compliant Arabic labeling, including SPCs, brochures, labels, IFUs, and artworks.