Clinical Trials Phase I–IV
GCP-compliant human pharmacokinetic and multi-center clinical trials for dietary supplements and botanical drug applications.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, SuppliersDiscover turnkey R&D, clinical trial execution, active ingredient screening, and custom chromatographic analytical method development services.
GCP-compliant human pharmacokinetic and multi-center clinical trials for dietary supplements and botanical drug applications.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
Target-driven cellular bioassays, enzymatic receptor screening, and HPLC-monitored molecular interaction analyses.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
In vivo efficacy screening, metabolic profiling, and toxicity tracking utilizing advanced chromatographic biospecimen profiling.
OEM Animal study Supplier, Suppliers
High-throughput natural active ingredient identification separating polyphenols, saponins, and functional alkaloids.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
HPLC, UHPLC, GC, and HPTLC assay development adhering to ICH Q2(R1) guidelines for linearity, precision, and robustness.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Multi-batch chromatographic fingerprint evaluation correlating geographical origin, seasonal harvest, and therapeutic potency.
ODM Study and evaluation of the potency of the botanical active ingredient(s)
Chromatographic preparative separation, macroporous resin column isolation, and solvent gradient recovery engineering.
Explore Botanical Extraction Process Optimization
cGMP batch production of finished natural medicines, softgels, granular extracts, and high-purity phytochemical powders.
Request Finished Dosage CDMO Production ProtocolsAddressing the strict chemical quantification demands of global regulatory bodies through robust liquid chromatography and stationary-phase engineering.
In the characterization of complex biological matrices and multi-component Traditional Chinese Medicine (TCM) compounds, chromatographic stability and resolution represent the foundation of quality assurance. MedGence applies systematic High-Performance Liquid Chromatography (HPLC) and Ultra-High Performance Liquid Chromatography (UHPLC) coupled with Photodiode Array (PDA), Evaporative Light Scattering Detectors (ELSD), and Triple Quadrupole Mass Spectrometry (LC-MS/MS) to establish empirical quality indices.
Scaling analytical methods to industrial contract manufacturing demands linear stationary phase translation. Our manufacturing engineering group integrates analytical column chemistry (sub-2-micron to 5-micron C18, C8, HILIC, and chiral packings) directly with preparative high-pressure stainless steel columns up to 1000 mm diameter. This eliminates peak splitting and band broadening across pilot-scale extractions and commercial batch crystallizations.
Bridging domestic botanical agricultural biodiversity with internationally validated pharmaceutical-grade industrial production capacity.
Eliminate secondary broker layers. Our facilities coordinate directly with GAP-certified domestic agricultural origins across Hunan, Sichuan, Yunnan, and Guizhou, mapping seasonal potency variances directly to chromatographic yield specs.
Benefit from vertically integrated infrastructure. From automated continuous countercurrent solvent extractors to automated high-capacity HPLC verification labs, manufacturing overheads drop by 30–45% compared to Western counterparts.
We supply complete Common Technical Document (CTD) analytical dossiers. Every batch export is matched with verifiable Certificates of Analysis (COA), HPLC chromatograms, heavy metal screenings, and stability protocols complying with US FDA, EMA, and NMPA standards.
Discover how intelligent automation, 2D-HPLC, and green analytical chemistry are transforming botanical active development and manufacturing efficiency.
Orthogonal chromatographic systems (combining non-aqueous reversed phase with hydrophilic interaction chromatography) resolve isomeric complexes that traditional one-dimensional systems miss.
Applying neural networks to real-time UV and Mass Spec elutions isolates overlapping active fractions, predicting stability profiles and shortening method validation cycles by 60%.
Transitioning from hazardous chlorinated solvents to Supercritical Fluid Chromatography (SFC) and ethanol-water gradients, reducing carbon emissions and regulatory solvent residue hazards.
Integrating inline automated HPLC probes with commercial extraction lines to monitor concentration curves instantly, enabling closed-loop feedback and zero batch failures.
Tailoring chromatographic specifications to market-specific compliance profiles, consumer labeling requirements, and operational safety limits.
Designed for FDA 21 CFR Part 111 dietary supplement rules. Methods verify exact potency claims on Supplement Facts panels, identify potential adulterants, and validate stability across real-time shelf life.
Methods calibrated to European Pharmacopoeia (Ph. Eur.) criteria. Focuses on total chromatographic fingerprint comparability, low pyrrolizidine alkaloid (PA) detection, and pesticide residue limits (EC 396/2005).
Quantitative evaluation of botanical bioactives (such as glabridin, resveratrol, and madecassoside) for skincare formulations, ensuring solvent-free residual guarantees and batch color stability.
Over 100 top-tier pharmaceutical conglomerates, research institutions, and university medical hospitals rely on our R&D and analytical execution.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Group
Dihon Pharma
Golden Throat
Yangtze River Pharma
Gofar Chuanshan
Humanwell Healthcare
SCIMYTH Pharma
Hanfang Pharma
Luoxin Pharma
Zhongsheng Pharma
Brilliance & Abundance
Apeloa Pharma
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Santo Pharma
Kangshou Pharma
Juwang Pharma
Tcmages Pharma
Ruihe Pharma
Jinchan Pharma
Kangmei Pharma
Tianjicaotang Pharma
Kingstone Unite
Shuguang Hospital
Hunan Prov. TCM Hospital
First Hospital Hunan TCM
Second Xiangya Hospital
Second Hospital Hunan TCM
Zhuzhou Orthopedics TCM
Clear, expert responses to support scientific review, regulatory audits, and international procurement evaluation.
From raw botanicals to shelf-ready commercial releases, select the operational service package that aligns with your timeline and target markets.
Translating preclinical chromatographic pharmacokinetics into robust, verifiable multi-phase human clinical outcomes.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
Target verification utilizing specialized enzymatic binding curves and quantitative chromatography.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Comprehensive LD50, acute, sub-chronic, and genotoxicity evaluations with quantitative HPLC tissue assays.
OEM Animal study Supplier, Suppliers
Advanced isolation of rare botanical monomers, providing structural identification and yield verification.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Turnkey transfer of validated chromatographic testing methods directly to client QC laboratories globally.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Rigorous evaluations of bioavailability across harvest batches, optimizing formulation excipient matrices.
ODM Study and evaluation of the potency of the botanical active ingredient(s)
Stability-tested complex natural formula blending, resolving solubility and degradation issues.
Explore Complete Natural Formulation Research
Direct bulk supply of analytical-grade active ingredients, standardized powders, and stable botanical concentrates.
Request Technical Catalogs & API QuotationsWhether establishing an orthogonal HPLC method for a novel botanical active, verifying compendial USP/EP monograph parameters, or scaling up to multi-ton contract manufacturing, our team delivers the data-backed assurance your business requires.