Annual Consulting

• Domestic & Overseas Regulatory Consultation & Interpretation
• On-site Coaching
• Mock Audit
• Domestic & Overseas Regulatory Training
• Corporate Compliance Consultancy
• Global Market Access Route Planning for Products
• Process Validation Optimization Advice

Preparations

• Pre-registration Preparation
• R&D & Verification
• Registration Application Planning
• Plant & Workshop
• GMP System
• Pilot Production

Inspection & Evaluation

• Registration Testing
• Biological Evaluation
• Animal Testing
• Clinical Evaluation
• Clinical Trials

Application & Review

• Dossier Preparation
• Pre-acceptance Consultation
• Acceptance
• Supplementary Request & Expert Meeting
• GMP System Inspection
• Registration Approval

Licensing & Amendments

• Manufacturing License Application
• Business License Application
• Registration Modification
• Registration Renewal

Post-market Management

• Instructions Revision
• Other Post-market Matters

Annual Consulting

• Domestic & Overseas Regulatory Consultation & Interpretation
• On-site Coaching
• Mock Audit
• Domestic & Overseas Regulatory Training
• Corporate Compliance Consultancy
• Global Market Access Route Planning for Products
• Process Validation Optimization Advice

United States

• Medical Device Registration Classification
• Q-Sub/Pre-Sub Pre-Submission Consultation
• Medical Device 510(k) Premarket Notification
• Enterprise Registration & Product Listing
• PMA Premarket Approval (For High-Risk Class III Devices)
• Quality System Compliance

European Union

• Market Access Strategy
• Technical Documentation & Clinical Services
• Quality & Risk Management Systems
• Software & Digital Health Compliance
• Packaging & Labeling Compliance
• Audit & Inspection Preparation

Other Countries

• Japan
• Southeast Asia
• Middle East
• Australia