From single active ingredient identification to multiregional clinical trial support, our turnkey OEM research pipelines bridge botanical biodiversity and standardized medicinal applications.
Rigorous protocol design, patient cohort management, biomarker tracking, and ICH-GCP compliant clinical execution for natural pharmaceuticals and functional supplements.
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Comparative chemometric mapping to quantify target active variations across seasonal cycles, altitudes, soil chemistry, and harvested botanical parts.
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Mass spectrometry and bio-affinity purification targeting alkaloid, polyphenol, and polysaccharide isolates with defined therapeutic indications.
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Comprehensive toxicology profiling, LD50 evaluation, bioavailability kinetics, and metabolic disease target validation in GLP-standardized laboratory models.
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Method transfer, chromatographic fingerprinting, and quantitative validation utilizing HPLC-DAD, LC-MS/MS, GC-FID, and high-performance HPTLC.
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High-resolution cell line screening, free-radical scavenge modeling, trans-epithelial transport permeability, and receptor-binding efficacy verification.
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Preparative separation of secondary botanical metabolites, structural elucidation via qNMR, and bio-fractionated molecular library curation.
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Trace contaminant profiling, pesticide residue mitigation (EP/USP compliant), heavy-metal assaying, and DNA barcoding for authentic species identification.
View Service DetailsThe global botanical extract market has moved beyond primitive ratio-extracts. Commercial viability now hinges upon reproducible chemical fingerprints, strict heavy metal isolation, and validated pharmacological modes of action.
Phytochemical extraction is inherently vulnerable to wild-harvest depletion, geo-climatic disturbances, and unpredictable agricultural pesticide use. Leading multinational entities require contract partners operating controlled cultivation traceability that meets both Chinese GAP and international WHO-GACP guidelines. Our integrated infrastructure bridges this deficit by executing seasonal potency mapping across diverse ecological biomes.
Historic reliance on coarse extraction ratios (e.g., 10:1 or 20:1) lacks scientific repeatability and fails stringent regulatory scrutiny. Modern procurement standards mandate absolute quantification of defined molecular targets—such as total ginsenosides, epigallocatechin gallate (EGCG), or artemisinin—using validated HPLC assays and isotopic standard verifications to eliminate batch variations.
Global regulators enforce zero-tolerance thresholds for ethylene oxide (EtO), polycyclic aromatic hydrocarbons (PAHs), mycotoxins, and organochlorine residues. Contract extraction operations require certified clean extraction fluids, inert closed-circuit distillation, and membrane purification to guarantee uninterrupted market entry throughout North America, Europe, and Asia-Pacific.
Our Changsha R&D center and state-of-the-art pilot extraction facilities serve as the scientific backbone for China's most demanding pharmaceutical consortiums, research universities, and global nutraceutical developers.
Our engineering ecosystem resolves common formulation pain points—such as insolubility, thermal degradation, rapid oxidation, and low systemic absorption—through proprietary extraction and galenic formulation science.
Multi-target screening systems identifying biologically potent small molecules from raw botanical matrices. We cross-reference empirical ethnobotanical databases with molecular docking to isolate candidates with optimized affinity for targeted metabolic pathways.
Systematic quantification of active compound synthesis across varying soil chemistries, harvesting seasons, and specific plant anatomies (root, bark, seed, flower) to guarantee cost-efficient procurement without biodiversity over-exploitation.
Development of chromatographic fingerprints and quantitation methods compliant with USP, Ph. Eur., and ChP standards. Protocols include high-precision HPLC, HPTLC, GC-MS, and LC-MS/MS for unambiguous molecule verification.
Bench-to-pilot scaling studies balancing supercritical CO2 extraction, pressurized liquid solvent systems, membrane microfiltration, and vacuum band drying to maximize bioactive yield while minimizing thermal degradation.
Overcoming botanical formulation hurdles including hygroscopicity, poor flowability, strong odors, and astringency. Our pharmaceutical formulation team crafts stable crystalline powders, micronized granules, and microencapsulated suspensions.
Full safety characterization covering LD50 determinations, acute and sub-chronic toxicity studies, Ames bacterial reverse-mutation assays, in vitro mammalian chromosomal aberration, and rodent bone-marrow micronucleus tests.
Targeted biochemical assays evaluating cellular uptake, anti-inflammatory cytokine modulation (TNF-α, IL-6 inhibition), oxidative stress reduction, and enzymatic inhibition (e.g., alpha-glucosidase, lipase) for mechanistic dossier documentation.
Target disease efficacy verification in standardized animal disease models (metabolic syndrome, neuroprotection, hepatic lipid accumulation) to generate irrefutable dossier evidence prior to human clinical trials.
Turnkey clinical execution ranging from double-blind, randomized, placebo-controlled clinical trials (RCTs) for dietary supplements to full Phase I through Phase IV studies compliant with global New Drug Application (NDA) standards.
Leveraging deep traditional medicine archives and modern synergistic compound ratios, we craft novel multi-component formulations with fortified pharmacokinetics, protected by defensible international composition-of-matter patents.
Dedicated commercial synthesis of premium phytochemical bulk APIs and active botanical ingredients. Formats include high-density concentrated liquids, fine crystallization powders, aqueous pastes, and steam-distilled volatile essential oils.
Scalable, GMP-compliant finished dosage packaging spanning hard gelatin and hypromellose (HPMC) capsules, liquid-fill softgels, effervescent and chewable tablets, sterile oral ampoules, and direct-to-consumer sachet granules.
Deploying botanical products globally demands flawless navigation through divergent regulatory frameworks. We deliver localized CMC (Chemistry, Manufacturing, and Controls) technical dossiers mapped to primary regional authorities.
| Regulatory Body | Jurisdiction | Applicable Standards & Quality Mandates | Yineng MedGence Technical Deliverables |
|---|---|---|---|
| US FDA | United States | 21 CFR Part 111 (Dietary Supplements), 21 CFR Part 210/211 (cGMp API), NDI (New Dietary Ingredient) & GRAS Dossiers. | Target active validation, USP chromatographic identity assays, total pesticide residue screening (USP <561>), solvent limits (USP <467>). |
| EMA / HMPC | European Union | Traditional Herbal Medicinal Products Directive (THMPD 2004/24/EC), Ph. Eur. monographs, Annex 7 EU GMP. | Genotoxicity assays (Ames), PAH quantification (benzo[a]pyrene), chromatographic fingerprints, HMPC well-established use documentation. |
| Health Canada | Canada | Natural and Non-prescription Health Products Directorate (NNHPD), Natural Health Products Regulations (NHPR). | Product Licence Applications (PLA), master file submission, NPN safety-efficacy data, stability testing under Zone II conditions. |
| TGA | Australia | Therapeutic Goods Act (1989), Listed vs. Registered Complementary Medicines, TGA GMP inspection alignment. | Full CTD dossier modules, active ingredient assay validation, residual pesticide/solvent proof, stability dossiers. |
| NMPA | China | Chinese Pharmacopoeia (ChP) 2025 Edition, National Traditional Chinese Medicine Registration & Hospital Preparations. | Complete registration filings for classical formulas, botanical quality standard monographs, hospital preparation approval archives. |
Our phytochemically standardized active ingredients and formulation systems power high-efficacy consumer and medical end-products across international distribution channels.
Consumers increasingly reject vague herbal blends in favor of clinically validated health claims. We deliver standardized extracts calibrated to specific disease markers: berberine HCl for glycemic control, standardized curcuminoids with piperine or liposomal delivery for joint mobility, and high-potency withanolides for cognitive stress balance. Every active ingredient is supported by human clinical trial dossiers substantiate structure-function claims on packaging.
Navigating the boundary between herbal tradition and pharmaceutical rigor, we engineer defined active single-chemical entities (NCEs) and purified multi-component botanical drug candidates. With 22 innovative natural medicines already engineered by our R&D scientists, our team prepares full IND (Investigational New Drug) application data packages, safety toxicology profiles, and complete phase-appropriate clinical data.
The clean-label beauty industry requires bioactive phytochemicals with demonstrable cellular permeability and melanin-inhibition or collagen-synthesis properties. We formulate purified madecassoside, glabridin, and resveratrol solutions optimized for cutaneous transdermal diffusion, documented via in vitro 3D human skin model testing (EpiDerm) to satisfy European and American cosmetic safety requirements.
Our stage-gate development lifecycle eliminates technical risk through documented analytical deliverables at every milestone.
Target indication identification, botanical species authentication, seasonal potency profiling, and geographic harvest optimization.
Deliverable: Target Molecule Feasibility & Sourcing Dossier.
Development of chromatographic fingerprints (HPLC/HPTLC/GC), molecular reference standard validation, and raw herb specifications.
Deliverable: Validated Analytical Testing Procedures (SOPs).
Solid-liquid extraction modeling, solvent recovery systems, membrane filtration, column chromatography, and vacuum drying parameter definition.
Deliverable: Critical Process Parameters (CPP) & Pilot Scale Master File.
Cellular uptake assays, receptor-binding kinetics, acute/chronic toxicology in animal models, and genotoxicity safety verification.
Deliverable: Preclinical Non-Clinical Safety & Efficacy Package.
GCP-compliant double-blind human clinical trials, bio-marker endpoints tracking, pharmacokinetic/pharmacodynamic bioequivalence dossiers.
Deliverable: Full Clinical Trial CSR (Clinical Study Report).
Industrial scale extraction, batch manufacturing release under cGMP standards, finished dosage packaging, and global logistics coordination.
Deliverable: Finished Commercial Batches with Complete COA & Retention.
The convergence of computational chemistry, green engineering, and advanced biotransformation defines the next decade of botanical active substance development.
By coupling ultra-high-resolution LC-Q-TOF-MS metabolomic data with machine learning neural networks, we can predict the biological activity of secondary plant metabolites before laboratory extraction. This cuts screening timelines from months to days, rapidly flagging promising synergistic pairings within classic formulations.
Phasing out petrochemical solvents in favor of Natural Deep Eutectic Solvents (NADES) and subcritical water systems. These green solvents mimic plant cellular fluids, offering exceptional extraction selectivity for polyphenols and flavonoids while producing fully biodegradable, chemical-free extract residues.
Many valuable botanical actives suffer from poor oral bioavailability due to large molecular size or high polarity. Using immobilized enzymatic glycosylation and nano-emulsion encapsulation, we convert common precursors into rare active metabolites (such as transforming ginsenosides into rare Compound K) with up to 12-fold greater systemic absorption.
Our contracted R&D and supply networks support China's most respected pharmaceutical manufacturers, clinical hospital centers, and academic institutions.
Tongrentang Group
CR Sanjiu Pharmaceutical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharmaceutical
Golden Throat Group
Yangtzi River Pharma
Beihai Gofar Biological
Humanwell Healthcare
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharma Group
Zhongsheng Pharma
Brilliance & Abundance
Apeloa Pharmaceutical
Heng Chang Pharma
Baotou TCM Co.
Kamp Medicine Co.
Guangxi Santo Pharma
Kangshou Pharmaceutical
Juwang Pharma
Tcmages Pharma
Ruihe Pharmaceutical
CR Jinchan Pharma
Kangmei Pharmaceutical
Tianjicaotang Pharma
Kingstone Unite Pharma
Shuguang Hospital
Hunan Affiliated TCM Hosp.
First Hosp. of Hunan TCM
Second Xiangya Hospital
Second Hosp. of Hunan TCM
Zhuzhou Orthopedics TCM
Answers to common technical, regulatory, and commercial inquiries when choosing MedGence as your natural medicine CRO and CDMO partner.
Contact our project managers to request technical data packages, pilot sample batches, analytical monographs, or a custom quote.
Turnkey regulatory trial execution, biostatistical analysis, and complete data package assembly for global drug agencies and supplement authorities.
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Empirical quantification of chemical marker concentrations across regional variations and climate profiles to protect raw material yield stability.
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Affinity ultrafiltration and mass spectrometry identification isolating bioactive phytochemical components with targeted therapeutic efficacy.
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Pharmacodynamic validation, subacute toxicity profiling, pharmacokinetic absorption mapping, and bioavailability confirmation in GLP animal facilities.
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Development and transfer of validated HPLC, HPTLC, and GC methods for ingredient assaying, marker quantification, and identity verification.
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In vitro evaluation of enzyme inhibition, pathway transcription response, cellular anti-oxidation, and safety toxicity screening.
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High-resolution preparative chromatography resolving closely related isomers, active flavones, and targeted botanical alkaloids.
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Holistic monograph development pairing macroscopic botanical authentication, microscopic histology, and DNA molecular barcode confirmation.
View Service DetailsWhether you are screening novel botanical leads, resolving formulation stability roadblocks, or scaling cGMP extract volumes, our scientific team is ready to scope your project protocol.
