Project Management
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Strong execution in tech transfer, scale-up, IND filing, clinical trial supply, and NDA submission.
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Proven Record:
5000+:Research project;
150+: CMC package for IND;
200+:Approval for Clinical trials. -
Experienced in global IND filings and regulatory engagement, especially valuable for startups.
R&D Innovation Capability
We are scientists at heart—collaborative, curious, and solution-driven. We go beyond routine services to support clients working on the scientific frontier.
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30 +
Patents Filed
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100 +
Scientific Paper Published
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40 +
Proficiency Verifications
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300 +
Validated Testing Methods
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7 M+
Research Grants Funded (in US$)
Advanced Facilities and Expert Team for Preclinical Study
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A multidisciplinary team with over a decade of proven expertise in GLP-compliant studies, FDA regulatory submissions, pathology, and molecular biology
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Key labs equipped with specialized instruments for ophthalmic, pediatric, and bioanalytical research
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Accredited non-clinical lab with FDA/OECD GLP compliance, AAALAC certification for animal welfare, CMA & CNAS testing and calibration recognition, and robust QA system
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Access to ABSL-2, BSL-2+, and BSL-3 environments, full support for animal exams and testing
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Bio-Molecule Manufacturing Capacity
Flexible CMO Solutions for Biologics
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500L facilities for tox lots, process transfer, fed-batch, and perfusion
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2000L production for clinical and commercial supply
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Integrated R&D and QC support for seamless tech transfer
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Dedicated ADC manufacturing infrastructure
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Fill-finish solutions: aseptic vial, pre-filled syringe, and lyophilized formats
Quality
Quality Management System
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Quality Management System
Built on cGMP and ICH standards, our system ensures consistency and compliance across both research and manufacturing.
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Audit and Compliance
Audited over 100 times by clients and agencies; fully aligned with FDA, EU cGMP, and ISO quality standards.