Accelerate early-phase therapeutic development through our pre-clinical discovery protocols, chromatographic fingerprinting, and standardized analytical systems.
With more than 14 years of intensive natural medicine CRO/CDMO services, our technical teams provide full-cycle transfer protocols from raw botanical extraction through commercial production.
We work exclusively on an entrusted CRO/CDMO contract development model under rigorous non-disclosure agreements. Client formulation profiles, custom manufacturing techniques, and proprietary isolation data are kept strictly confidential to preserve your long-term IP superiority.
Avoid technical bottlenecks when transitioning from microgram laboratory screening to multi-ton industrial batches. Our integrated pilot laboratories and cGMP-aligned manufacturing facilities run validated processes directly overseen by veteran analytical chemists.
From in vitro cytological screening to GLP-compliant toxicological analyses (LD50, acute, sub-chronic, and genotoxicity profiles), our comprehensive dossiers provide transparent empirical verification required for global new drug registrations.
Modern therapeutics demand a transition from empirical herbal formulations toward exact bioactive quantification, verifiable safety files, and resilient production pipelines.
International regulatory authorities (US FDA, EMA, NMPA) increasingly mandate comprehensive chromatographic fingerprint profiles and multi-target marker quantification. Modern natural medicines must deliver batch-to-batch chemical uniformity comparable to synthetic small molecules.
Raw herbal material potency fluctuates drastically based on climate variations, soil profiles, and harvesting windows. Without empirical origin screening and seasonal tracking, finished commercial dosages risk unstandardized potency and batch rejections.
The global shift toward preventive functional medicine requires clinical validation for retail botanical claims. Brands that rely on unsubstantiated herbal powders are losing market share to clinically validated extracts backed by human pharmacokinetic studies.
Leverage our native-origin botanical sourcing networks, continuous flow extraction units, and centralized chemical engineering clusters for structural cost advantages.
Direct supply contracts across China's geo-authentic (Daodi) cultivation regions eliminate intermediaries, allowing rigorous baseline tracking from seed to harvest.
High-capacity countercurrent extraction, advanced macroporous resin columns, and molecular distillation units ensure maximal target recovery and lower solvent footprints.
Transition from benchtop method development to 1,000-liter pilot validation in weeks rather than months, speeding up supply readiness for prospective NDAs.
Our raw inventory buffering shields partners from domestic agricultural price shifts, securing fixed-rate output stability across multi-year purchase orders.
We bridge high-potency chemical compounds with target market consumption habits, engineering functional galenical forms tailored to specific therapeutic categories.
Custom multi-herb fractionations engineered to standardize berberine, corosolic acid, and active saponins. Validated via in vitro carbohydrate-hydrolyzing enzyme inhibition models to deliver consistent potency for functional oral liquids and chewables.
Purified polysaccharides and triterpenoids extracted using low-temperature membrane separations to avoid thermal degradation. Supplied as instant dispersible granules, micro-encapsulated powders, or softgel oils with tested bio-absorbability.
High-purity botanical preparations standardized for lipid-soluble sesquiterpenoids and flavonol glycosides. Prepared with proprietary taste-masking technologies to optimize sublingual tablets and oral suspension formats without bitterness.
| Active Ingredient Format | Finished Product Realization | Key Technological Advantage | Target Regulatory Framework |
|---|---|---|---|
| Standardized Extract Powders | Hard Gelatin & HPMC Capsules | Micro-encapsulated flowability, zero agglomeration | USP / Ph. Eur. Dietary Supplements |
| High-Density Viscous Pastes | Softgels & Liquid Encapsulations | Solvent-free dispersion, elevated bioavailability | TGA / NMPA Health Foods |
| Purified Volatile Oils | Sublingual Emulsions & Drops | Supercritical CO2 extraction, volatile preservation | Global Cosmetic / OTC Medicine |
| Aqueous & Ethanolic Concentrates | Sachet Granules & Functional Drinks | Instant water solubility, stabilized taste profiling | Clean-Label Nutraceutical Foods |
Modernizing botanical drug development by coupling historic TCM databases with predictive machine learning algorithms and green continuous chromatography.
By mapping multi-target natural ingredients against human proteomic data, our computational models identify synergetic pathways across multi-herb formulas, shortening discovery timelines from years to weeks.
Deploying coupled UPLC-Q-TOF-MS systems to construct high-density metabolic fingerprints, ensuring comprehensive compound mapping, heavy metal tracking, and pesticide residue prevention.
Where plant tissue yield is biologically limited, we develop complementary biocatalytic systems using engineered yeast strains, ensuring a reliable supply of scarce saponins and glycosides.
We support international audits and drug filings with comprehensive chemical, manufacturing, and control (CMC) technical files aligned with FDA, EMA, and Health Canada requirements.
Comprehensive analytical documentation formatted to ICH guidelines (Module 3: Quality) for seamless filing integration with overseas regulatory authorities.
ICP-MS screening across every production batch to ensure strict compliance with USP <232>/<233> standards for lead, arsenic, cadmium, and mercury.
Screening over 400 multiresidue pesticides via GC-MS/MS and LC-MS/MS, alongside residual solvent analyses confirming adherence to ICH Q3C limits.
Every commercial batch is supplied with complete Certificate of Analysis (CoA) documentation, retention samples, and full chain-of-custody tracking.
Clear answers covering our contract research partnerships, pilot parameters, scale transfers, and proprietary IP protections.
We provide full-lifecycle R&D and commercial supply for plant-derived actives. This covers raw botanical screening, origin and harvest potency validation, custom HPLC/GC analytical method setup, extraction process engineering, LD50/genotoxicity testing, in vitro cellular models, animal safety runs, Phase I–IV human trials, and industrial OEM/CDMO manufacturing of APIs and finished dosage forms.
All contract development and manufacturing engagements operate under strict, enforceable Non-Disclosure Agreements (NDAs). Process flows, solvent ratios, purification methods, and finished recipes are treated as private client property. We enforce isolated data rooms and segmented workshop protocols to protect your IP from early scoping through commercial output.
Depending on the molecular nature of the active compounds, our laboratories deploy High-Performance Thin-Layer Chromatography (HPTLC), High-Performance Liquid Chromatography (HPLC) coupled with DAD/ELSD/MS, Gas Chromatography (GC), and chromatographic fingerprinting to verify identity, quantitative purity, and batch-to-batch chemical consistency.
Yes. Our integrated pilot facilities and directly managed commercial plants bridge the gap between initial assays and bulk production. Because our research chemists work alongside our manufacturing engineers, parameters developed at the bench translate smoothly into commercial-scale runs without cross-vendor delays.
We supply active raw materials as concentrated liquids, spray-dried powders, dense pastes, and pure volatile oils. For finished commercial products, our lines deliver oral liquids, hard two-piece capsules, softgels, compressed tablets, effervescent tablets, and soluble dispersible granules.
Yes. We organize small-cohort human clinical trials for dietary supplement claims, as well as formal GCP-aligned Phase I, Phase II, Phase III, and Phase IV clinical studies designed to supply the empirical data packages required for new drug submissions.
Browse our core manufacturing and testing service portfolio, spanning clinical trials, in vitro efficacy assessments, and multi-herb formulation scaling.
