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, 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