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Services
Quality Management System
US FDA Premarket Notification and Premarket Approval
US FDA Premarket Notification and Premarket Approval
- Establishment of Quality Management System in line with FDA 21 CFR 820, ISO 13485:2016. ISO 9001: 2015.
- Gap analysis among quality system against requirements.
- Training and awareness on the implementation of the components of quality management system.
- Perform 2nd party audits.
- Service Charges in USD 10,200/- (Please contact us to provide you with a customized offer)
US FDA Premarket Notification and Premarket Approval
US FDA Premarket Notification and Premarket Approval
US FDA Premarket Notification and Premarket Approval
- Assisting entrepreneurs get their first product to market in the USA or Canada.
- Service Charges in USD 8,500/- (Please contact us to provide you with a customized offer)
European Medical Device Regulation
- Establishment of Technical Documentation in compliance with MDR (EU) 2017/745.
- Assistance on maintaining Medical Device Directive Requirements.
- Training on components of technical compliance such as Risk Management, Post Market Surveillance, Unique Device Identification, Medical Device Reporting, Corrective and Preventive Actions.
- Service Charges in USD 40,200/- (Please contact us to provide you with a customized offer)
Turnkey Solutions on Setting up a Medical and Pharmaceutical Industry.
- Assisting entrepreneurs to get an Investor for a new product commercialization.
- Consultation on patented or research product for its commercialization.
- Setting up a Medical Device or a Pharma Product Manufacturing Facility.
- Customized consultation on research and development of innovative medical devices and Pharmaceuticals.
- Service Charges in USD 80,900/- (Please contact us to provide you with a customized offer)