Customized Non-standard Detection Service

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Service Category

Service Content

Customization of highly customized fixtures and fixtures for customer needs

Bone screws、implants for surger-bone plates、Spinal Implant Constructs in a Vertebrectomy Model、Intervertebral Body Fusion Devices,etc

Customize highly customized test equipment for customer needs

Pump syringe、Positive-negative pressure machine,etc

Development and Verification of Analysis Method for Quality Control in Registration

Related substances (Organic impurities)

Inorganic impuritiesICH Q3D

Solvent residue(ICH Q3C R7

Gene toxic impuritiesICH M7

Study on Compatibility of Pharmaceutical Packages

Injection and ampoule bottles, cillin bottles, etc.

Spray and Polymer Material, Silin Bottle, etc.

Hemodialysis and flow through pipes, valves, etc.

Declaration and Registration

Application and Registration of API Packaging and Supplementary Drug Packaging

Application and Registration of Consistency Assessment for Generic Pharmaceuticals

Innovative Drugs Assist Research and Development

Production Class Verification

Cleaning validation

Sterilization validation

Production process verification, etc.