Healtech offers one-stop CRO services & solutions from early clinical development to commercialization for global pharmaceutical companies
Early Clinical Development
Early Clinical Development
•Phase Ⅰ、First-in-Man
•Phase Ⅱa Clinical Study，Proof of Concept
•PK, PK/PD
•Drug-Drug Interaction Study
•Food Effects Study
Phase Ⅱ-Ⅳ Clinical Trails
Phase Ⅱ-Ⅳ Clinical Trails
•Phase Ⅱb Clinical Strateg and Clinical Operations
•Phase Ⅲ Clinical Strateg and Clinical Operations
•Phase Ⅳ Clinical Strateg and Clinical Operations
•Generic Drug BE Study
•Third-party Audit
•Whole Process Quality Risk Management
NMPA Product Registration
NMPA Product Registration
•Review and Guidance of Registration Documents
•Submission of Registration Documents
•Registration Review and Communication
•Acquisition of Registration Certificate
Post-Marketing Study
Post-Marketing Study
• Pharmaceutical Economic Evaluation
• Adverse Drugs Reactions Monitoring
• Drug Life Cycle Management
• Clinical and Healthcare Big Data Analytics and Business Strategy
Medical Affairs
Medical Affairs
•Medical Plan and Consultation
•Clinical Trail Protocol and Ancillary Documents Writing
•Registration Documents Writing
•Medical Report (CTD Requirements, ICH GCP Standards) Writing
•Medical Translation
