In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for…
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Virginia Contract Research Organization Co., Ltd.
Founded in Taiwan in 1997, VCRO has expanded to China and the US. Specializing in contract clinical research for new drug development, VCRO excels in regenerative medicine and gene therapy. It is recognized as the most professional and experienced CRO in the Asia-Pacific region.
What we do
Service Scope
VCRO has been in the market for 28 years, providing a complete one-stop service from IND to NDA. From medical affairs, regulatory affairs, clinical operations, data management and statistics, to EDC remote electronic data capture systems and IWRS, VCRO supports a complete service structure with more than 600 case experience and has delivered 54+ US FDA IND and 98+ GCP inspection.
54+ US FDA IND
Cell therapy, CAR-T, LBP, Gene therapy, nucleic acid drugs , miRNA , NCE , 505b2……
News / Events
Breaking News
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U.S. FDA releases updated guidance on donor eligibility determination for HCT/Ps (Part 1.)
In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These updates replace and expand upon the 2007 guidance1 on donor eligibility determination, reflecting the current interpretation of regulatory requirements under 21 CFR Part 1271 Subpart…