China Product Regulations and Technical Path Consultation

China QMS Counselling

China Medical Device Distribution QMS Counselling

China Domestic Agent Service for Imported Medical Devices

Perennial Regulatory Consultant for Medical Devices in China

Master Files Submission of Raw Materials in China

Master Files Submission of Pharmaceutical Excipients in China

Master Files Submission of Pharmaceutical Packaging Materials in China

Safety Evaluation of Leachable Substances in China

Technical Support for Product Pre-test and Rectification in China

Risk Evaluation and Management

Product Classification Determination Request

Class I Medical Device Filing/Recording

Class II/III Medical Device Initial Registration

Class II/III Medical Device Registration Change

Technical Files Compilation

Product Testing Rectification Technical Support

Medical Device Registration Under the MAH System

Registration of Imported-to-domestic Products

Follow-up and Correction of Medical Device Registration Technical Review

Clinical Evaluation Report for Products that are Exempt from Clinical Trials

Clinical Evaluation Report for Adopting Clinical Trials or Clinical Application Data of the Same Variety Products

Clinical Evaluation Report for Adopting Overseas Clinical Trials Data

Clinical Evaluation Report for Adopting Real-world Data

Clinical Trial Documentation Preparation

Clinical Trial Audit

Clinical Trial Statistical Analysis

Clinical Trial Data Management

Implementation and Management of Clinical Research Projects

Chemical Characterization of Materials

Safety Evaluation for Extractables & Leachable Substances

Biocompatibility Testing

Microbiological Testing

Validation of Cleaning, Disinfection, Sterilization

Restricted Substance Testing

Cleaning Room Environment Validation and Process Water Testing