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