Explore our core preclinical validation programs, designed to bridge phytochemistry with reproducible translational pharmacodynamics.
Biopharmaceutical innovators, nutraceutical giants, and specialized dermatological developers face rigorous regulatory gatekeeping. Partnering with a dedicated OEM in vivo testing provider resolves critical structural bottlenecks.
Over 85% of early in vitro hits fail during mammalian transition due to non-specific binding, first-pass hepatic metabolism, and unexpected plasma clearances. Contracted OEM in vivo testing ensures physiological relevance across rodent and non-rodent matrices early in the pipeline.
Constructing AAALAC-accredited barrier facilities and maintaining SPF animal colonies requires tens of millions in capital expenditures. Global procurement teams utilize MedGence OEM models to eliminate high overhead while accessing fully vetted vivarium infrastructures.
Navigating divergent international regulatory frameworks—including US FDA 21 CFR Part 58, EMA Good Laboratory Practice, and NMPA requirements—demands comprehensive, multi-regional GLP documentation packages and auditable raw instrumentation traces.
MedGence (Yineng Pharma) converges historical phytomedicine mastery with advanced pharmacokinetic screening, providing institutional reliability for global contract projects.
Standard small-molecule assays evaluate single analytes. Our LC-MS/MS and chromatographic fingerprinting platforms enable parallel quantification of up to dozens of simultaneous botanical active compounds and secondary metabolites in whole blood and target tissue.
From single-dose rodent LD50 escalation to 90-day sub-chronic and 180-day chronic toxicity evaluations with detailed histopathology, our protocols establish accurate No Observed Adverse Effect Levels (NOAEL) for regulatory filings.
Validated in-house disease models spanning metabolic dysregulation (STZ-induced diabetes, NAFLD/NASH), inflammatory and autoimmune cascades (collagen-induced arthritis), neuroprotection, and oncological xenograft evaluations.
A closed-loop framework eliminating data drop-offs between wet discovery lab benches and pilot production facilities.
Screening active botanical fractions, seasonal and geographical batch-to-batch variations, establishing robust HPTLC/HPLC baseline fingerprints.
High-throughput enzymatic screening, 2D/3D cell viability, target binding affinity, and pathway-specific anti-inflammatory mechanisms.
Target indication evaluation in murine/rodent models, multi-analyte PK absorption, bioavailability, and GLP-compliant toxicological safety ranges.
Translating validated batch formulations into pilot plant and GMP manufacturing: liquids, capsules, softgels, granules, and refined extract powders.
Ensuring scientific validity through rigorous regulatory adherence and intellectual asset protection.
Every animal testing protocol is independently reviewed and supervised by an institutional animal ethics committee adhering stringently to the 3Rs (Replacement, Reduction, Refinement) philosophy and global welfare benchmarks.
Operate under strict bilateral Non-Disclosure Agreements with dedicated laboratory cleanrooms, independent data partitioning, and secure server archives ensuring proprietary chemical compositions and methods remain protected.
From initial design consultations to IND eCTD dossier formatting, our Changsha-based scientific teams work closely with global sponsors across US, EU, and Asia-Pacific time zones to provide seamless document verification.
Our collaborative research footprint covers top-tier Chinese pharmaceutical conglomerates, research academies, and provincial university hospitals.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi River Pharma
Beihai Gofar
Humanwell Health
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharma
Zhongsheng Pharma
Brilliance & Abundance
Apeloa Pharma
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Guangxi Santo
Hunan Kangshou
Jiangxi Juwang
Beijing Tcmages
Guizhou Ruihe
CR Jinchan
Kangmei Pharma
Tianjicaotang
Kingstone Unite
Shuguang Hospital
Hunan Prov. TCM Hospital
1st Affiliated Hosp. HUNUCM
2nd Xiangya Hospital
2nd Affiliated Hosp. HUNUCM
Zhuzhou Orthopedics TCM
Key technical, contractual, and regulatory considerations for sponsors evaluating our OEM in vivo preclinical testing capabilities.
Seamlessly contract related preclinical, bioanalytical, and manufacturing capabilities across our ecosystem.
