Regulatory Affairs Support
• Product Registration for Medical Devices.
• In - Country Representation
• Regulatory Consulting and Document service
• Outsourced Regulatory Solutions
• Reimbursement Consulting
• Support for Adverse Event Reporting and Product recalls
• Medical Device Regulatory Compliance training
• Quality Management System (ISO 13485-2016, GDPMDs) implementation for Medical Device Manufacturers.
• Clinical Evaluation/ Clinical Studies in Europe
Assessment & Market Analysis Support
• Feasibility Studies/Market Analysis/Due Diligence
• Development and Implementation of Sales and Marketing Strategies
• Customized Benchmarking and Customer feedback analysis.
Partner Management Process
• Evaluation of existing Distribution partners
• Research, selection and evaluation of suppliers and partners
• Distributor screening/ profiling process (Search, Qualification, Selection, follow-up)
• Training and Education of existing or new distributors for Medical Device Compliance and Regulatory
Strategic Consulting Solutions
• Support to establish Country HQ Subsidiary or Representative office
• Manufacturing process and pre-delivery inspections prior to shipment of your products
• Supply Chain Management, Logistics and Warehouse solutions
• CSO (Contract Sales Organization) Services/ Convenient Market Entry via our company pool