Explore our full-lifecycle development modules designed to transition complex natural compounds from botanical origin assessment to industrial scale execution.
OEM Animal study Supplier, Suppliers
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ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
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OEM In Vitro Test /Research Service Manufacturers, Suppliers
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ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
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China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
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China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
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High-Throughput Botanical Fractionation & Target Validation
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Origin-Specific Multi-Seasonal Phytochemical Fingerprinting
Learn MoreThe international landscape for natural botanical extracts is undergoing a paradigm shift from unstandardized crude extracts to precision-engineered, bio-chemically characterized phytochemical matrices.
Global regulatory bodies, including the US FDA (Botanical Drug Guidance), EMA (HMPC monographs), and NMPA, increasingly enforce rigorous multi-compound profiling over single-marker identification.
Crude dry-ratio declarations (e.g., 10:1) are being systematically abandoned in favor of quantified concentrations of active polyphenols, saponins, flavonoids, and alkaloids evaluated via validated HPLC-DAD-MS configurations.
Climate variability and geopolitical adjustments necessitate direct geographical mapping of secondary metabolites. The same botanical specimen yields divergent pharmacological actions based on regional soil chemistry, altitude, and seasonal collection windows.
MedGence establishes comprehensive origin matrices to safeguard global B2B clients against critical supply disruption and batch inconsistencies.
Industrial supply demands zero solvent residue (EP/USP compliance), elimination of organochlorine pesticides, and verifiable absence of heavy metal ions through strict ICP-MS screening.
Green chemistry techniques such as supercritical fluid CO2 extraction and advanced subcritical aqueous isolation provide high bio-activity yield without synthetic footprint.
Forward-thinking brands are no longer purchasing commodity ingredients; they are co-developing proprietary botanical platforms fortified by clinical pharmacology and intellectual property moats.
Integrating high-content phenotypic screening with chromatographic fraction collection accelerates the isolation of functional ligands from centuries-old traditional recipes.
By connecting bioassays directly with high-resolution MS libraries, industrial lead times for finding therapeutic drug candidates or potent functional cosmetics are reduced by over 60%.
Natural phytochemicals frequently exhibit low native bioavailability, low water solubility, and swift systemic elimination. Advanced CDMO processing introduces liposomal delivery systems, self-emulsifying micro-suspensions (SEDDS), and specialized micro-encapsulation.
This allows oral dosage formats (softgels, capsules, functional beverages) to deliver elevated clinical plasma levels at lower raw material concentrations.
Global regulatory oversight demands concrete pharmacodynamic and pharmacokinetic documentation. Off-the-shelf marketing extracts are failing import clearances.
Contract research organizations provide the bridging gap, delivering accredited OECD-GLP animal model evaluations, cytological studies, and human clinical trial validation to support FDA Structure/Function claims and EFSA article dossiers.
Tailored technical specifications engineered to address regional legislative constraints, consumer dosage preferences, and specific commercial end-use requirements.
Engineered for high-speed automated encapsulation and tableting presses. We provide spray-dried, free-flowing, directly compressible granulates and botanical extracts with standardized densities.
Fully compliant with DSHEA labeling regulations, non-GMO requirements, third-party ID tests (DNA/HPTLC), and stringent limits on microbiological load and solvent residues.
Solvent-free, pasteurized liquid extracts, hydro-glycolic fractions, and lipophilic natural essential components adapted for skin barrier penetration and cosmetic formulation compatibility.
Every active batch is verified for non-cytotoxicity via in vitro cell assays (3D reconstructed human epidermis), conforming with EU Cosmetics Regulation (EC) No 1223/2009 and clean-label benchmarks.
Direct modernization of recognized Traditional Chinese Medicine (TCM) compounds into water-soluble concentrated granules, sterile oral solutions, and softgels.
We provide full CMC dossiers, chromatographic fingerprint homology studies (>0.95 similarity score across batches), and clinical dossier management for formal institutional hospital drug registration.
A methodical six-phase process translating uncharacterized botanical feedstock into validated, reproducible commercial batch production under airtight IP control.
Multi-regional harvesting across contrasting climatic zones and collection windows. Target compound mapping to pinpoint maximum bio-potency density.
Deliverable: Phytochemical Assay & Sourcing DossierDevelopment and validation of HPTLC, HPLC-MS/MS, and GC-FID assays. Construction of unique chromatographic fingerprints to prevent adulteration.
Deliverable: Method Validation Protocol (ICH Q2 R1)Optimization of solvent-to-solid ratio, temperature, dynamic countercurrent extraction parameters, column chromatography resins, and vacuum drying profiles.
Deliverable: Pilot Plant Critical Process Parameters (CPP)LD50 determination, Ames genotoxicity, acute and sub-chronic 90-day oral toxicity profiles, paired with mechanistic in vitro cell assays.
Deliverable: Preclinical Safety & Mechanistic ReportDouble-blind, placebo-controlled human trials for structural-functional claims, or comprehensive Phase I to Phase IV clinical study management for drug approval.
Deliverable: GCP-Compliant Clinical Trial ReportExecution of cGMP commercial batch manufacturing across powders, liquids, softgels, and tablets with complete batch documentation and secure supply logistics.
Deliverable: Finished Commercial Batch & Full COAOvercoming systematic manufacturing hurdles encountered by global pharmaceutical companies, nutraceutical giants, and clinical hospital institutions.
Many traditional herbal formulas fail modern commercialization due to variable efficacy and non-standardized multi-component interactions.
We provide full modern chemical characterization, clinical validation, and regulatory documentation, having modernized 83 classic formulas and achieved 56 registered hospital preparation approvals.
For therapeutic botanical drug development, target compounds must be purified to precise high-purity standards (>98%) while retaining cost-efficiency.
Our pilot plants utilize preparative chromatography, membrane filtration, and selective resin adsorption technologies to manufacture complex natural molecules from concentrated extracts.
Intellectual property leakage remains the foremost concern for brands outsourcing formulation and extraction R&D overseas.
Operating under strict bilateral non-disclosure frameworks, we ensure all analytical profiles, proprietary processes, and formulation data remain the exclusive intellectual property of the commissioning client.
Over 100+ industry leaders, university teaching hospitals, and publicly listed pharmaceutical innovators trust MedGence for contract research, analytics, and industrial manufacturing.
In-depth answers addressing regulatory feasibility, quality control standards, and technology transfer for global procurement and scientific directors.
MedGence delivers comprehensive end-to-end R&D services for botanical substances: active screening, seasonal/origin potency evaluations, analytical standard establishment (HPLC/GC/HPTLC), manufacturing process studies, toxicity evaluations, in vitro and animal studies, through to human clinical trials and finished product CDMO contract manufacturing.
Yes. Our in-house pilot development plants and industrial collaborative factories are directly steered by our technical scientific teams. Validated laboratory processes transfer smoothly into commercial production batches, avoiding knowledge gaps between independent laboratory researchers and contract manufacturers.
We deploy High-Performance Thin-Layer Chromatography (HPTLC) for qualitative identification, High-Performance Liquid Chromatography (HPLC) coupled with DAD/ELSD/MS detectors for quantification, Gas Chromatography (GC) for volatile components, and multi-peak chromatographic fingerprinting to secure batch-to-batch chemical equivalence.
We enforce rigorous bilateral non-disclosure protocols and an entrusted research structure. All formulations, batch production parameters, analytical methodologies, and chromatographic libraries remain the client's sole proprietary assets, shielded by stringent organizational data isolation protocols.
Active ingredients are manufactured as concentrated liquids, spray-dried micro-powders, semi-solid pastes, and purified volatile oils. Finished consumer products include sterile oral liquids, hard gelatin/vegetarian capsules, softgels, film-coated tablets, soluble powders, and effervescent granules.
Yes. We organize small-scale human clinical intervention trials to substantiate dietary supplement structure-function claims, as well as full-scale Phase I, Phase II, Phase III, and Phase IV clinical programs necessary to assemble comprehensive NDA botanical filings for regulatory authorities.
Access our pilot laboratories, analytical suites, and industrial extraction facilities. Consult directly with our senior scientific team in Changsha, Hunan.
OEM Animal study Supplier, Suppliers
Learn More
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
Learn More
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Learn More
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
Learn More
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Learn More
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Learn More
High-Throughput Botanical Fractionation & Target Validation
Learn More
Origin-Specific Multi-Seasonal Phytochemical Fingerprinting
Learn More