CDMO Total Solution
CDMO overall solution
Contract Development
System establishment
Product inspection
Clinical evaluation
Registration Application
Approval and Certification
Contract Manufacturing
Production and Launch
Entrusted R&D
Entrusted R&D & process development
Project feasibility analysis
Risk management
Product R&D
Raw material and process research
Product trial production
Verification and validation
Process optimization
R&D data output
01
System establishment
Quality management system guidance
System evaluation
Plan making
Regulations training
System data design and writing
System operation
Internal audit
Guidance and rectification
02
Product inspection
Product inspection service
Inspection agency screening
Personnel matching
Technical requirement confirmation
Material preparation
Sample inspection
Report tracking and acquisition
Data output
03
Clinical evaluation
Clinical evaluation service
Research institution screening
Clinical evaluation program design
Personnel matching
CRF design and collation
Clinical implementation and quality control
Clinical statistical analysis
Clinical report writing
Clinical project data output
04
Registration Application
Submission of Product Registration Materials
Product Category Definition
Registration Scheme Design
Application Materials Preparation
Technical Review Communication
Analysis of Corrective Requirements
Correction of Registration Materials
Administrative Approval Tracking
05
Contract Manufacturing
Contract Manufacturing Service
Effective Transfer of Production Technology Documents
Production Line Equipment
Process Optimization
Production Training
Application for Production License
Large-scale Production
Compliance Routine Management
06
Service Hotline
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