Transforming complex botanical entities into reproducible, ICH-GCP compliant clinical evidence. End-to-end preclinical profiling, human pharmacokinetics, and Phase I–IV clinical validation managed in high-throughput Chinese research facilities.
Direct factory access to standardized phytochemistry assays, bio-potency evaluations, safety bio-assessments, and translational Phase I–IV trial management.
The confluence of unprecedented botanical biodiversity, high patient enrollment density, advanced analytical instrumentation, and competitive capital expenditure creates a distinct global procurement advantage.
Running multi-center botanical clinical trials in China provides a 40% to 65% cost efficiency compared to North American or Western European CRO equivalents, without compromising ICH-GCP or WHO compliance guidelines.
Partnered with 33+ grade-A tertiary hospitals and TCM academic clinics across Hunan, Shanghai, and Jiangxi, enabling expedited volunteer recruitment across cardiometabolic, immunological, and chronic inflammatory indications.
Direct geographical access to wild-crafted and GAP-cultivated medicinal plant germplasms ensures zero supply degradation between raw biomass harvesting, active chemical fingerprinting, and pilot-scale GMP trial manufacturing.
Equipped with ultra-performance chromatographic systems, tandem mass spectrometry (LC-MS/MS, GC-MS), and automated multi-batch fingerprinting to establish unambiguous chemical consistency for regulatory submissions.
Our strict contract research protocol guarantees full intellectual property custody. Proprietary formula fractions, extraction kinetics, and clinical biomarker results remain 100% confidential under robust NDA and non-compete agreements.
We deliver data packages aligned with US FDA Botanical Drug Guidance, EMA Herbal Medicinal Products Committee (HMPC), and NMPA standards, eliminating translation gaps during global licensing transactions.
Years of Specialized Botanical CRO/CDMO Execution
Dedicated Scientists & Analytical Researchers
Classic TCM Formulas Modernized & Trialed
Registered Hospital Preparations Approved
The paradigm of clinical research for plant-derived therapeutics has pivoted from rudimentary empirical documentation toward multi-omics deconvolution, digitized monitoring, and molecular target docking.
High-content cellular screening combined with machine-learning algorithms enables researchers to rapidly predict synergistic mechanisms across complex polyphenol and saponin matrices, reducing early exploratory timelines by up to 60%.
Regulatory agencies such as the US FDA and European EMA reject single-marker validation. The modern standard demands full multi-wavelength HPLC/GC fingerprinting to guarantee that the extract administered in Phase III trials is chemically identical to the proposed commercial batches.
By leveraging digital health tools, continuous patient telemetry, and decentralized blood-sampling kits, modern clinical trial manufacturers maintain significantly higher patient compliance and reduced dropout rates across long-term chronic studies.
Whether contracting for an individual preclinical assay or an end-to-end translational study package, our unified methodology provides clear deliverables at every critical milestone.
Quantifying variations in active secondary metabolites across divergent harvest seasons, botanical parts, and growing terroirs. We lock down the highest yielding chemotype before initiating process chemistry.
Deliverable: Phytochemical Profiling DossierEstablishing sensitive HPLC, HPTLC, and GC-MS fingerprints to verify compound identities, impurity baselines, pesticide residues, and heavy metals according to pharmacopeial monographs.
Deliverable: Method Validation Report (ICH Q2)Optimizing extraction, vacuum concentration, chromatographic fractionation, and spray drying to preserve thermolabile compounds and produce uniform, cGMP clinical trial batches.
Deliverable: Pilot Batch CoA & Master FormulaAssessing safety and cellular pharmacology via cell line viability assays, bacterial reverse mutation (Ames), acute oral LD50, and 90-day subchronic systemic toxicity rodent models.
Deliverable: Comprehensive Preclinical Safety DossierConducting randomized, double-blind, placebo-controlled clinical trials (Phase I PK/PD safety, Phase II dose-finding, Phase III multi-center efficacy, and Phase IV post-market surveillance).
Deliverable: CSR (Clinical Study Report)Transitioning validated formulations into commercial-scale solid oral dosage manufacturing (tablets, softgels, two-piece hard capsules, oral liquids) with strict IP segregation.
Deliverable: Commercial Supply AgreementTailored contract development models that serve international pharmaceutical innovators, functional food enterprises, and dermocosmetic manufacturers.
For biopharma organizations pursuing prescription botanical drugs, we engineer complete chemical, manufacturing, and control (CMC) packages along with Phase I–III human clinical trials supporting global regulatory registration.
Substantiating high-value structure/function claims for consumer brands through gold-standard human pilot trials. We provide statistically powered evidence for gut health, metabolic balance, cognitive performance, and joint mobility.
Translating traditional phytocomplexes into verified topical skincare solutions. Supported by human patch tests, anti-inflammatory biomarker profiling (IL-6, TNF-alpha), collagen synthesis assays, and clinical skin barrier evaluations.
Procuring custom clinical studies and companion active ingredients requires strict technical risk mitigation. MedGence guarantees full auditability across all five procurement pillars:
Over 14+ years our scientific team has delivered formulation development, analytical method validation, and clinical research for China's most prestigious healthcare groups.
Tongrentang Group
CR Sanjiu Medical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharmaceutical
Golden Throat Group
Yangtzi River Pharma
Humanwell Healthcare
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharma Group
Shuguang Hospital TCM
Essential information for clinical operations leads, sourcing specialists, and chief scientific officers evaluating an OEM clinical study partner in China.
Select individual research modules or integrate your entire development pipeline with our Changsha scientific campus.
