🤝 Strategic Advisory & RA Team Support – Medical Devices

Our Strategic Advisory and Regulatory Affairs (RA) Team Support service helps medical device manufacturersdevelop and execute effective regulatory strategies to ensure smooth market entry and long-term compliance in the UAE, GCC, and European markets.

We work as an extension of your internal RA team or as your dedicated regulatory partner, providing expert guidance from early product development to post-market support.

Our service includes:

• Regulatory strategy development tailored to your target markets
• Product classification, risk-based regulatory route mapping, and timelines
• Pre-submission consultations with regulatory authorities (e.g., MoHAP, SFDA, CE Notified Bodies)
• Support with internal RA team workflows, document preparation, and regulatory planning
• Strategic input during product lifecycle stages: development, registration, renewal, or change management

With LIS Consulting as your regulatory partner, you gain a proactive, expert-driven approach to navigating complex and evolving regulatory frameworks for medical devices.

🌐 Market Access Planning

Our market access consulting is designed to help you achieve successful product launches:

• Regional market research and competitor analysis
• Entry strategy development for medical devices and IVDs
• Support for tenders and local distributor engagement
• End-to-end support from registration to commercialization