MORE TRANSPARENCY, HIGHER EFFICIENCY AND LOWER COST
Traditional Business Model
Optimal Business Model
O U R F A C I L I T I E S
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​Ambient Room (15 ~ 25 ℃)
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Cold Room (2 ~ 8 ℃)
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Freezer Storage Room (-20 ℃ & -80 ℃)
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24/7 Temperature and Humidity Monitoring System
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Inventory Management System
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Access Control Security System
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Full Area Coverage Camera System
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Fireproof Filing Cabinet
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1.5M kW Backup Generator
Q U A L I T Y A S S U R A N C E
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Registered with US FDA under FEI 3020085632
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Successful EU QP Declaration
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Strict SOPs in compliance with FDA, EMA, NMPA, TFDA, etc.
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Inventory management system
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Senior management team has an average of 30+ years of experience in top pharmaceuticals worldwide
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A functional and effective team
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Cloud and hardcopy data storage
O U R T E A M
Over 20 years of experience in pharma R&D and BD at Eli Lilly, Merck, and GenScript​
Successfully led ACTS and completed over 50 global clinical trials (Phases I-III)
Provided RLD/Comparators to more than 400 pharma clients
Over 40 years experience in Pharmaceutical QA, Clinical QA, and regulatory compliance including 26 years at Pfizer as a senior leader​
Provided regulatory and compliance support to clinical and commercial internal and 3ʳᵈ party sites around the globe​
Directed a team of internationally based auditors, assessors, and QA support staff
Larry Yu, MD, PhD
Founder & CEO
John Mandy
Quality Assurance Lead
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