Regulatory Affairs Support
• Product Registration for Medical Devices in Asia.
• In - Country Representation in Asia.
• Regulatory Consulting and Document service in Asia
• Outsourced Regulatory Solutions for international and local companies in Asia with limited regulatory resources.
• Reimbursement Consulting for specific Asian countries
• Support for Adverse Event Reporting and Product recalls in Asia.
• Medical Device Regulatory Compliance training for international and local companies in Asia.
• Quality Management System (ISO 13485-2016, GDPMDs) implementation for Medical Device Manufacturers and distributors in Asia
• Clinical Evaluation/ Clinical Studies in Europe
Assessment & Market Analysis Support
• Feasibility Studies/Market Analysis/Due Diligence for various Asian markets.
• Development and Implementation of Sales and Marketing Strategies for Asia.
• Customized Benchmarking and Customer feedback analysis for various Asian markets
Partner Management Process
• Evaluation of existing Distribution partners in Asia.
• Research, selection and evaluation of suppliers and partners in Asia.
• Distributor screening/ profiling process (Search, Qualification, Selection, follow-up) in Asia.
• Training and Education of existing or new distributors for Medical Device Regulatory Compliance in Asia
Strategic Consulting Solutions
• Support to establish Country HQ Subsidiary or Representative office in Asia.
• Manufacturing process and pre-delivery inspections prior to shipment of your products in selected countries in Asia.
• Supply Chain Management, Logistics and Warehouse solutions in selected countries in Asia.
• Access to the local markets through our CSO (Contract Sales Organization) Services/ Convenient Market Entry in Singapore, Malaysia, Indonesia, Thailand, Vietnam, Cambodia, Australia, India and Philippines
