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I. Clinical evaluation
II. Clinical Trial Design and Management
III. Post market surveillance:
- Legal Assessment
- Technical Assessment
- Market Assessment
- Core competency Assessment
IV. R & D of Pharmaceuticals
V. Laboratory Design and Certification Service
1.TAF lab
2.GTP
VI. Intellectual Property and Patent Applications
VII. Educational and Professional Training Programs
VIII. Quality Control and Assurance
IX. Post-Market Surveillance of Medical Devices
X. Overall Marketing Services
XI. Procurement of Market Approvals through FDA、CE、TFDA、Japan etc.
XII. Consulting Services including Regulatory Affairs and Legal Affairs on Malpractice |
I. Medical Devices – “from Concept to Market”
1. Class I & II
2. Class III
3. Class of Tissue Engineering Products
4. Combination Products of Drugs, Devices & Biologics
II. Cell Therapy
III. New Drug development
IV. Vaccines
V. Health Foods& medicalfood
VI. Cosmetics |
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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 |