Procure certified protocol execution, high-resolution botanical characterization, and batch-tested manufacturing across our accredited CRO/CDMO pipelines.
The contract research and manufacturing sector for plant-derived therapeutics is transitioning from unstandardized crude extraction toward high-dimensional metabolomic phenotyping, AI target deconvolution, and strict cGMP compliance.
Traditional suppliers supplied crude botanical powders with high batch-to-batch variation. Modern OEM researchers now isolate single-target alkaloids, polyphenols, and saponins with documented chromatographic purity (>98%), resolving historical bioequivalence disparities.
High Purity ChemistrySiloed development models are obsolete. Contemporary pharmaceutical enterprises demand contract partners capable of bridging computational active ingredient screening directly into kilogram-scale pilot extraction and final cGMP oral solid dose manufacturing.
Vertical IntegrationOEM research must deliver defensible regulatory packages. Partnering institutions now furnish complete Common Technical Documents (CTD Module 3 Quality, Module 4 Nonclinical), ensuring full harmony with FDA, EMA, and NMPA market entry mandates.
Harmonized ICH Q2Moving beyond anecdotal TCM utility, OEM researchers utilize automated high-content phenotypic screening in tandem with metabolomics to identify synergistic ligand-receptor cascades, delivering mechanistic clarity demanded by Western regulatory bodies.
Target DeconvolutionBiopharmaceutical and health-brand procurement executives navigate severe supply-chain volatility, unverified chemical fingerprints, and disparate cross-border regulatory statutes.
Variations in soil geochemistry, altitude, harvest cycles, and ambient moisture alter secondary metabolite accumulation, causing active biomarker swings exceeding 300% between industrial vendor lots.
Commercial ingredient suppliers frequently lack certified in vitro cellular assays and GLP animal safety dossiers (LD50, Ames, micronucleus), resulting in catastrophic rejection during regulatory review.
Outsourcing extraction know-how to commoditized brokers invites formulation leakage and patent circumvention. Global procurement requires cryptographically secure, entrusted research safeguards.
MedGence (Yineng Pharma) executes twelve synchronized research, engineering, and clinical capabilities engineered to de-risk natural compound development from initial assay to multi-ton release.
High-throughput automated fractionation to isolate alkaloids, polyphenols, saponins, and functional polysaccharides. We determine highest-yield taxonomic sources while balancing commercial availability and ecosphere preservation.
Discovery PhaseQuantitative assaying of target moieties across diverse geographical origins, microclimates, harvesting seasons, and specific plant anatomical structures (radix, folium, semen, cortex) to establish the ideal commercial procurement window.
Agronomic ProfilingCreation and formal ICH Q2(R1) validation of assay methodologies employing HPTLC, HPLC-DAD, GC-MS, and multi-wavelength chromatographic fingerprinting for unambiguous identity, purity, and active biomarker verification.
ICH Q2(R1) ValidatedEngineering pilot-scale extraction, continuous counter-current isolation, resin column chromatography purification, and freeze/spray drying to maximize active yield while drastically lowering solvent consumption.
Chemical EngineeringOvercoming botanical organoleptic liabilities, compound hygroscopicity, poor gastrointestinal solubility, and chemical degradation during solid/liquid dose manufacturing to preserve pharmacological active retention.
Formulation ScienceRigorous non-clinical toxicology programs covering LD50 quantification, acute dermal/oral toxicity, sub-chronic repeated dose exposure (28/90 days), bacterial reverse mutation (Ames), and in vivo genotoxicity.
GLP Safety ProfilingTargeted bioassays across immortalized human and mammalian cell lines (Caco-2, HepG2, RAW 264.7) providing rapid proof-of-concept data for metabolic regulation, inflammatory pathway suppression, and antioxidant pathways.
Cellular ScreeningTranslational animal pharmacology verifying in vivo potency in rodent metabolic disorder models, neurobehavioral assessments, and chronic inflammatory states, establishing crucial dose-response baselines for human translation.
Translational In VivoICH-GCP compliant protocol authoring, IRB/IEC approval navigation, and clinical trial monitoring for Phase I pharmacokinetic/safety studies through Phase II/III pivotal trials and post-market dietary supplement human trials.
GCP Clinical DossiersRe-engineering classical polyherbal formulations using modern systems pharmacology, molecular synergy mapping, and precise active compound standardization for next-generation integrative therapeutics.
Synergy ModelingSupply of custom-isolated active moieties in industrial formats: high-viscosity liquid extracts, standardized micronized powders, purified pastes, and fractional essential volatile oils with batch release certificates.
Bulk CDMO SupplyTurnkey cGMP manufacturing of commercial retail formats: oral liquids, softgels, vegetarian/gelatin two-piece capsules, precision-coated tablets, effervescent powders, and micro-granules under pharmaceutical environmental controls.
Finished Dosage cGMPEnsuring frictionless global market entry through full alignment with United States FDA Botanical Drug Guidelines, European Medicines Agency (EMA) Herbal Monographs, and Asian NMPA filings.
Compilation of Chemistry, Manufacturing, and Controls (CMC) packages satisfying the FDA Botanical Drug Development Guidance for Industry. Comprehensive 21 CFR Part 111/211 compliance, New Dietary Ingredient (NDI) submissions, and GRAS (Generally Recognized As Safe) scientific expert consensus dossiers.
Alignment with the Committee on Herbal Medicinal Products (HMPC) Community Herbal Monographs. Full documentation supporting Traditional Herbal Medicinal Products Directive (THMPD 2004/24/EC) and EFSA Novel Food Article 10 safety data submissions.
Streamlined pathway for Class 1 and Class 2 Innovative Traditional Chinese Medicines and Hospital Preparation registrations in China. Validated manufacturing and testing data tailored to Australian TGA GMP audits and Japanese Ministry of Health PMDA standards.
Harnessing artificial intelligence, microfluidic continuous extraction, and high-resolution multi-omics to redefine the boundaries of botanical pharmacology.
Deploying deep graph neural networks (GNNs) to predict molecular docking kinetics between complex phytochemical libraries and orphan human disease targets, accelerating lead identification by 70%.
Replacing batch maceration tanks with continuous flow micro-reactors. Enhances mass transfer coefficients, lowers heat exposure duration, and preserves delicate thermolabile bioactive sesquiterpenes.
Implementing non-targeted HR-LC-MS/MS metabolomic fingerprinting to detect low-abundance trace metabolites, ensuring absolute chemical parity across cross-continental commercial batches.
Over 14 years of dedicated institutional contract research, serving Tier-1 pharmaceutical conglomerates, university hospital consortia, and international retail brands.
Years of Pure Natural Medicine R&D Specialization
Senior Scientists, Pharmacognosists & Lab Engineers
Pharma Manufacturers & University Hospitals Served
Classic TCM Formulas Successfully Modernized
Novel Plant-Derived Medicines Brought to Pipeline
Hospital Preparation Clinical Registrations Acquired
Single-Herb Quality Standards Established
Intellectual Property Escrow & Traceability
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Yangtzi River Pharma
Humanwell Healthcare
Direct responses addressing analytical thresholds, clinical transfer, CDMO production scalability, and proprietary IP protections.
Commission research protocols, analytical method establishment, or commercial-scale CDMO supply directly with our scientific and engineering team.
Submit your target indication, intended dosage format, or target chemical marker. Our principal pharmacognosists and regulatory scientists will assemble a customized study scope, analytical validation roadmap, and quotation within 48 business hours.
