Verified clinical and preclinical study pipelines supporting dietary supplement brands, active ingredient manufacturers, and natural medicine innovators worldwide.
Botanical raw materials are inherently complex chemical matrix systems. In modern pharmaceutical, nutraceutical, and cosmaceutical development, traditional crude extraction is being replaced by systems-level botanical provenance studies, targeted metabolomics, and mechanistic biological validation.
A single species grown in different geographical microclimates (Daodi terroirs) or harvested at divergent phenological stages exhibits major fluctuations in secondary metabolites, including polyphenols, triterpenoids, and alkaloids.
Moving beyond ambiguous efficacy claims. Through high-throughput screening and multi-omics, our studies decipher how multi-component herbal mixtures exert synergistic biological actions on human cellular receptors and biological cascades.
Strict compliance with US FDA Botanical Drug Development Guidance, European EMA Monograph thresholds, and USP standards requires total batch-to-batch chemical fingerprint uniformity (similarity coefficient > 0.95).
China offers an unparalleled synthesis of indigenous raw herb biodiversity (Daodi regions), advanced chemical extraction industrial parks, and world-class academic bio-analytical talent, providing massive speed-to-market advantages.
With our scientific center situated in Changsha, Hunan, our factory networks link directly to prime cultivation bases across Hunan, Guangxi, Yunnan, and Guizhou. We bypass commodity traders to acquire virgin botanical materials with fully authenticated agronomic histories.
Our integrated model unites research benchwork with dedicated pilot workshops and GMP commercial scale production lines. Customers avoid the 12–18 month delays and transfer yield losses common when contracting research and manufacturing to separate overseas entities.
Our laboratories maintain cutting-edge LC-MS/MS, GC-MS, ICP-MS, and automated extraction reactors. This enables ultra-trace detection of environmental impurities, heavy metals, pesticide residues, and mycotoxins according to strict pharmacopeial standards.
From raw botanical discovery and chromatographic standardization to preclinical safety dossiers, human clinical evaluations, and commercial formulation manufacturing.
Systematic isolation and fractionation of plant biomass to isolate target alkaloids, polyphenols, triterpenoid saponins, and functional polysaccharides. High-density yield-optimization matching market pricing targets.
Quantitative assessment mapping how altitudinal gradients, harvest seasonality (spring vs. autumn flushes), and specific anatomical parts (root, rhizome, bark, leaf, aerial) impact target chemical yields.
Development and ICH-compliant validation (linearity, precision, recovery, ruggedness) of HPTLC identification, HPLC-DAD assay methods, chiral separations, and fingerprint similarity protocols.
Engineering supercritical CO2 extraction, countercurrent solvent extraction, macroporous adsorption resin purification, membrane ultrafiltration, and vacuum band drying to maximize bio-potency.
Resolving critical botanical drug delivery hurdles: poor aqueous solubility, bitter organoleptic profiles, hygroscopicity, low bioavailability, and excipient cross-reactivity.
Execution of oral LD50 assays, 28-day and 90-day sub-chronic repeated dose rodent toxicological assessments, Ames bacterial reverse mutation tests, and in vivo chromosomal aberration profiles.
Primary cell culture assays and immortalized cell lines (RAW 264.7 macrophage anti-inflammatory, HepG2 lipid metabolism, Caco-2 permeability, B16 melanogenesis inhibition assays).
Targeted animal models for metabolic syndrome, neuroprotection, hepatic injury, arthritis, and immunomodulation with comprehensive biochemical, cytokine, and histopathological readouts.
GCP-compliant human efficacy studies for nutraceutical structure-function dossiers, alongside Phase I PK/PD, Phase II dose escalation, and Phase III multicenter clinical trials for botanical IND/NDAs.
Deciphering classical compound formulas (Fangji) via modern pharmacodynamic methods. Establishing chemical signature biomarkers for multi-herb classical hospital prescriptions.
Custom industrial-scale bulk manufacturing: concentrated extracts, standardized powdered botanical extracts, standardized soft extracts, and volatile botanical essential oils.
End-to-end contract packaging and manufacturing: oral liquids, hard-gelatin and vegetarian HPMC capsules, softgels, precision tablets, micro-pellets, and instant soluble granules.
Procurement directors and quality managers from international pharma and dietary brands face stringent oversight. Our botanical source research and manufacturing directly answer the toughest supply-chain mandates.
Adulteration with cheaper analog species represents a major hazard in botanical procurement. Every source evaluation study utilizes DNA barcoding (ITS2, rbcL, matK markers) alongside microscopic identification and secondary metabolite fingerprint matching to guarantee 100% taxonomic purity.
We ensure continuous compliance with the United States Pharmacopeia and European Pharmacopoeia. Raw materials and finished extracts undergo testing for ethylene oxide (EtO), polycyclic aromatic hydrocarbons (PAHs), heavy metals (Pb, Cd, As, Hg), and microbial bioburden.
Under strict mutual Non-Disclosure Agreements (NDAs), client proprietary formulas, extraction fractionation ratios, and manufacturing technology are safeguarded. IP generated during contracted research belongs exclusively to the sponsor.
Whether structuring a botanical drug candidate for investigational drug filings or scaling a clean-label clinically substantiated nutraceutical line, our research workflows fit distinct industry requirements.
Standardized extracts formulated for metabolic support, cognitive health, immune priming, joint mobility, and sleep improvement. Backed by human double-blind placebo-controlled data.
Complete preclinical CMC (Chemistry, Manufacturing, and Controls) dossiers, impurity profiling, and GLP-standardized safety testing matching FDA Botanical Drug Development guidance.
Isolated bioactive botanical actives optimized for transdermal penetration, anti-glycation, radical scavenging, barrier repair, and collagen stimulation, validated through 3D skin models.
MedGence (Yineng Pharma) brings over 14 years of natural medicine CRO/CDMO leadership, modernizing heritage botanical formulas with rigorous chemical validation and hospital-grade research standards.
Clients can initiate engagement at any milestone or commission the entire end-to-end development cycle. Every stage generates concrete analytical data and regulatory deliverables.
Multi-region sourcing trials, phenotypic assay, and comparative marker densitometry across harvest seasons and geographical locations.
Deliverable: Sourcing & Terroir ReportCreation of validated HPLC-DAD / GC-MS assays, HPTLC visual identification methods, and multi-wavelength chemical fingerprint specifications.
Deliverable: Validated QC Specification PackageBench-to-pilot scaling of solvent extraction, temperature curves, resin loading kinetics, crystallization, spray drying, and particle sizing.
Deliverable: Pilot Batch Manufacturing Record (BMR)Execution of GLP acute toxicity (LD50), 90-day repeated dose toxicological studies, mutagenicity testing, and targeted disease animal models.
Deliverable: Preclinical Toxicology DossierDouble-blind, placebo-controlled human dietary supplement trials or GCP Phase I–IV clinical programs supporting botanical IND/NDA registration.
Deliverable: Audited Clinical Study Report (CSR)GMP production of standardized concentrated bulk liquids, high-potency dry extracts, or fully packaged capsules, softgels, tablets, and powders.
Deliverable: Commercial Lots + Full CoAsComprehensive answers clarifying how our research workflows, confidentiality protections, quality standards, and CDMO operations serve overseas pharmaceutical and nutraceutical clients.
Review our contract research services and initiate pilot screening batches, assay validation protocols, or commercial CDMO production orders.
Partner with China's leading natural medicine research group. Send your desired botanical targets, therapeutic areas, or regulatory requirements to receive a customized study protocol and quotation.
