ODM Clinic Study (Phase 1 - Phase 4)
Human pharmacokinetic trials and clinical efficacy validation compliant with ICH GCP standards.
View Service DetailsDirectly access verified CDMO and analytical processes engineered to address the world’s most stringent pharmacokinetic and regulatory standards.
Human pharmacokinetic trials and clinical efficacy validation compliant with ICH GCP standards.
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Phytochemical compound isolation, fraction analysis, and density enrichment screening.
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Custom HPLC, GC-MS, and HPTLC chromatographic fingerprint development for release testing.
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Spatiotemporal quantification of bioactive molecules across seasons, geographies, and chemotypes.
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High-throughput molecular cellular assays, enzymatic receptor binding, and pathway screening.
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In vivo pharmacodynamics, dose escalation curves, biodistribution, and toxicology profiling.
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Commercial isolation of pure alkaloids, polyphenols, saponins, and polysaccharides at scale.
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End-to-end processing of softgels, compressed tablets, oral tinctures, and micro-granules.
View Service DetailsIn the modern botanical and natural pharmaceutical industry, procuring "Highest Quality" has evolved from simple raw material verification into complex supply chain orchestration, multi-target chromatography, and international regulatory readiness.
Moving beyond single-marker UV spectroscopy. Enterprise procurement requires holistic HPLC, GC-MS, and HPTLC spectrum mapping to prove that the botanical composition is free of synthetic adulterants and batch variations.
Rigorous adherence to USP <561> pesticide limits, USP <2232> elemental contaminants (Lead, Arsenic, Cadmium, Mercury), and zero-tolerance microbial burdens (salmonella, aflatoxins) across wildcraft and farmed supply chains.
Leading brands require more than Certificates of Analysis; they demand validated toxicology portfolios, stability testing under ICH conditions (zone IVb), and scientific dossier generation ready for immediate FDA NDIN or EFSA filings.
MedGence (Yineng Pharma) operates as a single-source CRO & CDMO powerhouse based in Changsha, China, consolidating 14+ years of specialized TCM formulation and modern molecular medicine.
Systematic screening across alkaloids, polysaccharides, flavonoids, and terpenes using multi-target bioassays to identify active fractions yielding optimal therapeutic density and ecological scalability.
Quantifying variations in phytochemistry driven by altitude, microclimate, harvest timing, and anatomical plant parts (rhizome vs. aerial) to lock in raw supply channels of superior baseline potency.
Formulation of proprietary HPTLC, HPLC, GC, and chromatographic fingerprint standards to deliver uncompromising batch-to-batch consistency and forensic adulteration prevention.
Systematic optimization of countercurrent extraction, resin chromatography, nanofiltration, and lyophilization to maximize active recovery while lowering environmental footprint.
Overcoming formulation bottlenecks including volatile degradation, low aqueous solubility, and organoleptic bitterness to retain bio-potency across long-term shelf storage.
Execution of acute toxicity (LD50), 90-day sub-chronic toxicological regimes, Ames testing, and in vitro micronucleus genotoxicity testing fulfilling international safety thresholds.
Mechanistic validation spanning enzyme inhibition (e.g., alpha-glucosidase, COX-2), antioxidant radical scavenging, and cellular inflammatory cytokine suppression (TNF-α, IL-6).
Establishing efficacy curves in validated animal models of metabolic disorder, hepatoprotection, cognitive decline, and immune response to deliver reliable preclinical proofs.
Managing GCP-certified human trials from pilot exploratory evaluations for nutraceutical claim substantiation up to complete Phase I–IV clinical data for NDA registrations.
Harmonizing ancient classical formulas with molecular synergy, backed by a clinical track record of modernizing 83 classic Traditional Chinese Medicine preparations.
Supplying enterprise quantities of customized botanical pure extracts, vacuum-dried crystals, concentrated liquids, and standardized volatile oils under full IP isolation.
cGMP commercial manufacture of capsules, softgels, functional oral liquids, micro-tablets, and water-dispersible granules ready for multi-national consumer markets.
Our institutional capacity rests upon measurable achievements supporting China’s premier state-owned pharmaceutical conglomerates and research institutions.
Navigating from empirical natural extraction to precision biotechnology, artificial intelligence multi-omics, and green carbon-neutral manufacturing.
Employing machine learning models to analyze thousands of secondary plant metabolites against targeted human cell receptor maps, reducing discovery timelines from years to months.
Replacing volatile organic petroleum solvents with Supercritical Fluid Carbon Dioxide (scCO2) and subcritical water extraction systems to guarantee zero chemical solvent residues.
Deploying advanced lipid bilayer encapsulation and targeted cyclodextrin complexation to dramatically boost the bioavailability of notoriously insoluble polyphenols and curcuminoids.
Developing cellular enzymatic biotransformation pathways for rare and endangered botanical compounds, eliminating pressure on wild biomass while retaining chemical bio-equivalence.
Mitigating cross-border operational risk with dedicated project managers, internationally compliant data pipelines, and impenetrable non-disclosure environments.
Direct preparation of technical paperwork matching US FDA 21 CFR Part 111/211, European Union EFSA novel food validation, Health Canada NPN dossiers, and Chinese NMPA standards.
Operating under strict bilingual Non-Disclosure Agreements (NDA) and segmented clean-room production schedules ensuring that proprietary client formulations and process logic remain isolated.
Every overseas partner is assigned a specialized English-fluent technical lead, bridging real-time communication for analytical method transfer, protocol changes, and rapid pilot scheduling.
Our validated analytical standards and manufacturing solutions power the supply chains of China's most historic pharmaceutical icons and premier medical research hospitals.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi 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
Guangxi Santo
Kangshou Pharma
Juwang Pharma
Tcmages Pharma
Ruihe Pharma
CR Jinchan
Kangmei Pharma
Tianjicaotang Pharma
Kingstone Unite
Shuguang Hospital
Hunan Affiliated TCM
1st Hosp Hunan TCM
2nd Xiangya Hosp
2nd Hosp Hunan TCM
Zhuzhou TCM OrthoClear answers to regulatory, technical, and operational inquiries for global brands evaluating an integrated botanical contract manufacturer.
Procure bulk botanical extracts or commission turnkey finished dosage developments engineered under full pharmacopeial compliance.
Institutional Review Board (IRB) monitored human trials for medical claims validation.
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High-resolution fractionation and identification of previously uncharacterized phytomolecules.
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Custom QC assay validation conforming directly to USP, EP, and ChP statutory guidelines.
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Optimizing supply chain yield curves by analyzing seasonal harvest kinetics.
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Cell viability, receptor-binding assays, and anti-inflammatory cellular pathways.
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Rodent pharmacokinetic modeling, oral bioavailability assessments, and safety endpoints.
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Industrial supply of crystallized pure bio-actives and high-titer natural standardized powders.
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Full encapsulation, tableting, blister-packaging, and bottled finished formulation execution.
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