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.Medical product from concept to market consulting
.Support biotechnology industry problem solving
.Market assessment、technology assessment、law assessment
.Medical product development and commercialization consulting
.In Vitro test、in vivo test、GTP、GLP、GMP
.Medical issue & Malpractice、Advertisement and regulation of
medicine product
.DOH、FDA、CE、SFDA etc
.Biotechnology service Integration
.Organization alignment service
.Medical product risk assessment .Medical product research and design
.Lab consulting (GLP, GTP, GMP) .Medical product regulation consulting
.Identification and license .Intellectual property and patent
.Animal testingt .Clinical trial (Human trial)
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Clinical trial plan and design
.Clinical trial protocol and study design planning
.Selection of medical institutions and investigators
.Making of written informed consent form and manual
for filling in CRF
Clinical trial protocol writing and application
.Included and excluded criteria
.Safety and endpoint assessment
.New drugs clinical trial application
.Medical device clinical trial application
Clinical trial monitoring
.GCP compliance
.Clinical study reports
.Adverse reaction report (ADR、AE、SAE)
.Clinical process auditing and monitoring
Clinical trial data management
Clinical trial protocol assessment |