Empowering global enterprises with rigorous botanical validation, analytical standards, and clinical-grade evidence packages.
Clinical human trials and translational evaluations from Phase 1 to Phase 4 for botanical drug registrations.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
Cellular and enzymatic mechanistic pathway assays verifying biological potency prior to animal protocols.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Methodology development using HPLC, HPTLC, and fingerprinting for qualitative and quantitative active-content QC.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Systematic origin and temporal batch quantification protecting commercial supply against batch-to-batch variation.
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
High-throughput screening across plant parts to identify high-density phytochemical compounds with clear therapeutic windows.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Controlled in vivo preclinical models evaluating LD50, metabolic action, safety tolerances, and dose-response kinetics.
OEM Animal study Supplier, Suppliers
Regulatory-compliant clinical documentation, GCP monitoring, and multi-center clinical trials for dietary and pharma NDAs.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
ICH-aligned assay development, molecular fingerprinting, and standardized validation protocols for global registration.
China Establishment of analysis methods of active ingredient(s) Supplier, SuppliersNavigating raw material integrity, regulatory divergence, and reproducible phytochemical yields in enterprise supply chains.
Enterprise buyers face mounting scrutiny concerning raw botanical adulteration, synthetic spiking, and seasonal batch inconsistency. Traditional extraction vendors often lack chemical marker assays, resulting in unverified bioactive percentages that fail stringent monograph testing.
Phytopharmaceutical sourcing requires strict alignment with region-specific pharmacopeias (USP, Ph. Eur., ChP). Formulations destined for multinational distribution must satisfy evolving limits on heavy metals, mycotoxins, pesticide residues, and microbial load.
Splitting early-stage analytical development, bioassay validation, and commercial scale-up between siloed entities causes communication loss, IP exposure, and formulation drift. Market leaders increasingly demand turnkey CRO/CDMO partners delivering end-to-end accountability.
Combining over 14 years of specialized natural medicine R&D with modern chromatography, pharmacology, and industrial cGMP manufacturing.
We utilize proprietary analytical databases and targeted assays to pinpoint specific alkaloids, flavonoids, polyphenols, and saponins. By identifying high-yield botanical cultivars and seasonal windows, we optimize raw input economics while maintaining consistent bioactivity.
High-performance thin-layer chromatography (HPTLC), HPLC-MS, and GC testing methods are designed and validated under ICH guidelines. We create chemical chromatographic fingerprints that guarantee precise batch-to-batch identification and quantify marker compounds.
Our preclinical laboratory executes cellular target profiling alongside comprehensive in vivo safety models, including acute (LD50), sub-chronic toxicity, and mutagenicity/genotoxicity assessments to qualify dosage safety before clinical transition.
We run structured pilot clinical evaluations for high-tier nutraceutical claims, as well as formal GCP-compliant Phase I–IV clinical studies in university hospital settings to support official New Drug Applications (NDAs) and botanical drug registrations.
With modern translational science applied to 83 classic Traditional Chinese Medicine formulas, we resolve bitter off-notes, precipitation issues, bioavailability deficits, and solvent residues to convert historic wisdom into compliant modern forms.
Production scales smoothly from pilot runs to multi-ton commercial output. Finished dosage formats include oral liquids, enteric-coated softgels, hard capsules, functional tablets, and water-soluble micro-granules produced in cGMP-certified environments.
Over a decade of demonstrated execution across China's foremost pharmaceutical groups and global herbal innovators.
Structured, gate-controlled milestones that mitigate technical risk from screening to global regulatory submission.
Target phenotype screening, solvent extraction optimization, seasonal potency mapping, and active biomarker verification.
Development of HPLC/HPTLC analytical assays, chemical fingerprinting, purification studies, and pilot-scale process validation.
In vitro mechanistic assays, animal pharmacokinetics, acute/chronic toxicology dossiers, and dosage safety profiling.
Scale-up to commercial batch manufacturing, clinical trials (Phase I-IV), NDA submission dossier readiness, and commercial supply.
Direct technical stewardship ensuring compliance across North American, European, and Asian life-science markets.
Assistance with US 21 CFR Part 111 (Dietary Supplements) and Part 210/211 (Finished Pharmaceuticals), Botanical Drug Guidance packages, and NDIN notifications.
Formulation and dossier optimization conforming to EMA Herbal Medicinal Products Committee (HMPC) guidelines, Traditional Herbal Medicinal Products Directive (THMPD), and Ph. Eur. monographs.
Clear IP ownership structures protected by comprehensive non-disclosure agreements, segregated laboratory runs, and dedicated manufacturing production campaigns.
Detailed answers covering tech transfer, assay methods, quality standards, and contract manufacturing.
Select validated capabilities below to review technical specifications, study methodologies, and contract manufacturing options.
Phase 1 to Phase 4 clinical trial packages for botanical pharmaceuticals and high-potency functional foods.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
Target-specific in vitro testing to validate biological mechanisms, cellular uptake, and active bioavailability.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Methodology transfer and validation for qualitative and quantitative assays in compliance with global pharmacopeias.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Comparative geographical and seasonal potency studies ensuring optimized harvest times and source origins.
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
Phytochemical screening to identify, isolate, and quantify candidate therapeutic compounds in plants.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
In vivo preclinical evaluations including toxicology, pharmacokinetics, and dose-ranging efficacy studies.
OEM Animal study Supplier, Suppliers
High-content cell-based assays targeting specific enzyme receptors for preliminary functional screening.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
High-throughput identification of active fractions in rare and medicinal plant species for proprietary product lines.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers