Preclinical study services | GLP、 GTP、GMP consulting
Clinical trial design & management | Medical devices
Quality system | Regenerative medicine(tissue engineering)
Health insurance provided consulting| Cell therapy and gene therapy
Medical regulation consulting| Health food
Diagnosis of bio-enterprise| Cosmeceutical
 
     
 

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 testingtClinical trial (Human trial)



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