Explore our specialized natural medicine CRO/CDMO service units spanning raw molecular screening, method validation, in vitro bioassays, and clinical scale-up.
Navigating international supply chains, evidence-based botanical standardization, and analytical modernization for global pharmaceutical and nutraceutical innovators.
Classic Chinese Herb Formulas—historic multi-herb combinations documented in canonical pharmacopoeias—represent one of the world's most intricate biological systems. Historically relied upon through decoctions and experiential formulations, modern international regulatory authorities (including the US FDA Botanical Drug Guidance, EMA Herbal Medicinal Products Committee, and NMPA Class 1.1/3.1 botanical directives) now enforce strict chemical consistency, multi-marker fingerprinting, and clear mechanistic pathways. Global B2B buyers no longer merely procure raw herbs; they seek qualified Contract Research and Development Organizations (CRO) and Contract Development and Manufacturing Organizations (CDMO) capable of validating bioavailability, establishing batch reproducibility, and managing high-throughput clinical programs.
Potency starts at the source. Seasonal harvesting variations, altitudinal stress, soil micro-elements, and authentic regional cultivars (Daodi herbs) drastically influence secondary metabolite yields. MedGence institutes origin-to-clinic tracking, preventing volatile content fluctuations in classic formulations.
Single-marker testing cannot capture multi-herb synergies. Our R&D centers implement dual-wavelength HPLC-DAD, LC-MS/MS, and high-performance thin-layer chromatography (HPTLC) to create 2D chromatographic maps, locking formula stability across hundreds of commercial production batches.
Exporting to European and North American markets requires compliance with stringent pharmacopoeial residual thresholds. Our manufacturing protocol integrates automated supercritical CO2 purification, subcritical low-temperature separation, and heavy metal microfiltration.
Over 14+ years of dedicated laboratory investigation, botanical CDMO synthesis, and accredited clinical drug evaluation.
Entrusted by Tier-1 Chinese pharmaceutical giants, public Class-3A hospitals, and international supplement innovators to supply batch-consistent active ingredients.
Proprietary botanical active medications researched, tested via animal efficacy models, and advanced through regulatory clinical trials.
Formulations officially registered for hospital inpatient use, verifying therapeutic outcomes across diverse therapeutic patient demographics.
Zero third-party disclosure under trusted bilateral contract terms. We safeguard your client trade secrets, solvent ratios, and clinical findings.
Bridging molecular identification to finished commercial dosage forms through evidence-based engineering.
Extracting high-value polysaccharides, saponins, flavones, and alkaloids. We analyze botanical components to locate targeted bioactive pathways while reducing environmental and solvent waste.
Evaluating active marker fluctuations across harvest windows and geoclimatic zones to specify standard operating procedures for raw material sourcing.
Developing validated quantitative assays using HPLC, GC, and chromatographic fingerprints compliant with USP, Ph. Eur., and Chinese Pharmacopoeia (ChP).
Engineering pilot-scale industrial parameters: continuous countercurrent extraction, resin column absorption, nanofiltration, and low-temperature freeze drying.
Overcoming botanical formulation hurdles including hygroscopicity, oxidation, poor solubility, and bitter gustatory profiles for maximum consumer acceptance.
Comprehensive toxicity dossiers: median lethal dose (LD50), Ames genotoxicity testing, 90-day repeated-dose oral toxicity, and cellular teratogenicity evaluation.
Targeted cellular response testing for blood glucose modulation, enzymatic inhibition (DPP-4, ACE), anti-inflammatory cytokine suppression, and antioxidant screening.
Rodent disease models evaluating multi-organ metabolic function, neuroprotection, and immune support to establish statistically robust proof-of-concept evidence.
GCP-compliant double-blind clinical trials for botanical New Drug Applications (NDA) and pilot human exploratory trials for regulatory label health claims.
Scientific re-engineering of historical classics (e.g., Liu Wei Di Huang, Xiao Yao San) with optimized decocting dynamics and verified modern metabolic actions.
Reliable bulk contract supply of standard standardized concentrated liquids, atomized extract powders, herbal pastes, and volatile steam-distilled essential oils.
Commercial-scale cleanroom lines delivering cGMP oral liquids, vegetable capsules, enteric-coated softgels, functional granules, and micro-tablets.
How computational biology, network pharmacology, and green chemistry are modernizing ancient remedies for mainstream medical recognition.
Classic formulas function through holistic synergies. Utilizing molecular docking and network pharmacology, we identify exact ligand-receptor interaction hubs across physiological cascades.
Data Deliverable: Computational Affinity MapsPhasing out harmful petrochemical solvents. We employ pressurized green solvent technologies to maximize thermo-sensitive glycoside yield while lowering industrial carbon footprint.
Data Deliverable: 99.4% Solvent Recovery RatioAddressing the poor intestinal permeability of botanical saponins and flavonoids through liposomal encapsulation, nanoemulsions, and cyclodextrin supramolecular complexes.
Data Deliverable: 3x-6x Bioavailability CurveA transparent, traceable milestone workflow designed for overseas procurement heads and pharmaceutical project leads.
Locating verified botanical specimens across regional plantations. Verifying active marker concentrations across multiple harvest cycles.
Deliverable: Sourcing & Potency DossierBuilding high-precision HPLC/HPTLC testing methods and raw botanical monographs to verify inter-batch consistency.
Deliverable: Validated QC MonographsAdjusting temperature, solvent polarity, and drying methods to optimize commercial production yield without thermal compound degradation.
Deliverable: Pilot Batch Scale-Up ParametersComprehensive toxicity trials (LD50, genotoxicity) coupled with cellular and animal bioassays to prove biological efficacy.
Deliverable: Preclinical Toxicology PackageHuman safety trials, PK/PD profiling, and efficacy verification satisfying pharmaceutical NDA submissions or dietary structure-function support.
Deliverable: Clinical Study Registry DatasetReliable production of liquids, powders, capsules, and granules with batch-release COAs and cold-chain international delivery.
Deliverable: Commercial Batches & COAProviding evidence-based contract services and classic formula extraction for premier healthcare organizations across the globe.
Beijing Tongrentang
CR Sanjiu Pharmaceutical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharmaceutical
Golden Throat Holdings
Yangtzi River Pharma
Beihai Gofar Biological
Humanwell Healthcare
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharmaceutical
Zhongsheng Pharma
Hunan Brilliance TCM
Apeloa Pharmaceutical
Hunan Heng Chang
Baotou TCM Co.
Kamp Medicine
Guangxi Santo Pharma
Hunan Kangshou Pharma
Jiangxi Juwang Pharma
Beijing Tcmages Pharma
Guizhou Ruihe Pharma
Anhui CR Jinchan
Kangmei Pharmaceutical
Tianjicaotang Pharma
Kingstone Unite Pharma
Shuguang Hospital Shanghai
Hunan Prov. TCM Hospital
1st Affiliated Hosp. HUCM
2nd Xiangya Hospital CSU
2nd Affiliated Hosp. HUCMHarmonizing Chinese botanical preparations with global pharmacopoeial monographs and consumer market legislation.
Analytical methodologies validated against United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and British Pharmacopoeia (BP). Tests confirm absence of heavy metals (ICP-MS), pesticide residues (GC-MS/MS), and aflatoxins.
Manufacturing facilities operate in strict accordance with ISO 9001, ISO 22000, and pharmaceutical-grade GMP guidelines. Controlled humidity, positive air pressure, and automated CIP/SIP sanitation prevent microbial cross-contamination.
ICH-standard accelerated and long-term stability chambers (Zone IVb conditions: 30°C/75% RH and 40°C/75% RH). Comprehensive shelf-life dossiers verifying secondary compound degradation kinetics over 24 to 36 months.
Key scientific, commercial, and regulatory guidance on partnering with MedGence for classic Chinese herbal solutions.
MedGence delivers end-to-end preclinical and commercial execution: high-throughput active screening, seasonal & origin potency assays, HPLC/HPTLC analytical method development, extraction scaling, acute & chronic toxicity dossiers, in vitro cell assays, preclinical animal models, human clinical studies (Phase I–IV), and commercial OEM/CDMO production.
Yes. We translate ancient multi-herb recipes into quantitative botanical matrices. We map critical quality attributes (CQAs), validate active or surrogate chemical markers, eliminate heavy metals and pesticides, and compile comprehensive Chemistry, Manufacturing, and Controls (CMC) dossiers for IND or novel food filings.
We deploy High-Performance Thin-Layer Chromatography (HPTLC) for identification, High-Performance Liquid Chromatography with Photodiode Array Detection (HPLC-DAD), Ultra-Performance LC-MS/MS, Gas Chromatography (GC-MS), and Atomic Absorption/ICP-MS for impurity quantitation.
We work under strict international bilateral Non-Disclosure Agreements (NDAs). Entrusted research formulas, solvent ratios, chromatography files, and process parameters remain the exclusive property of the client, ring-fenced within secure lab systems.
We supply both bulk botanical extracts (spray-dried powders, concentrated pastes, volatile oils, liquids) and retail-ready finished dosage forms including hard vegetarian/gelatin capsules, softgels, micro-tablets, functional effervescent granules, and sterile oral liquids.
Yes. Our clinical research associates arrange human sensory and bioavailability evaluations for dietary supplements, as well as formal GCP-compliant Phase I through Phase IV multicenter human trials required for botanical new drug approvals.
Select your target research phase or bulk CDMO service unit below to request batch trial samples or specification certificates.
