From single molecular phytochemical isolates to complex multi-target botanical fractions, explore our validated, traceable, and GMP-certified development matrices.
Global life science enterprises are shifting from raw powdered extracts to evidence-based botanical actives backed by clinical pharmacokinetics and verified chromatographic footprints.
Procurement directors in Europe, North America, and APAC face persistent hurdles: wide variations in seasonal biomarker concentrations, undocumented agrochemical residues, heavy metal contaminants, and supply chain vulnerability. Modern pharmaceutical and nutraceutical applications demand stable molecular purity, requiring suppliers to operate as scientific partners rather than simple trading brokers.
Under tightening FDA (NDI, cGMP 21 CFR 111), EFSA, and TGA regulations, botanical claims must withstand double-blind human clinical trials and in vitro mechanistic proof. Purchasing teams prioritize suppliers that supply verified batch chromatographic fingerprints, full genotoxicity profiles (Ames, Micronucleus), and clear pharmacokinetic bioavailability data.
With over 12,000 medicinal plant species and a centuries-old pharmacopeia, China holds unparalleled natural raw-material advantages. By integrating classical Traditional Chinese Medicine (TCM) regional sourcing ("Daodi" terroir) with ultra-modern extraction tech (SFE-CO2, continuous countercurrent, macroporous resin isolation), China serves as the world's premier innovation engine for botanical therapeutics.
Decades of accumulated multi-omics datasets, hospital registrations, and commercial batch delivery.
Years Dedicated Botanical CRO & CDMO Practice
Research Scientists, Pharmacologists & Analytical Chemists
Classic TCM Prescriptions Decoded via Modern Molecular Pharmacology
Single-Herb Quality Standards & Fingerprint Matrices
From single plant screening to full Phase IV multi-center hospital trials, we reduce translational friction at every development milestone.
Systematic phytochemical characterization across complex matrices. We separate alkaloids, polyphenols, triterpenoid saponins, and polysaccharides using target-receptor binding assays, surface plasmon resonance (SPR), and LC-MS metabolomics to isolate highest-potency leads.
Phytochemical concentration deviates by up to 600% depending on altitude, soil microbiota, and harvest windows. Our spatial-temporal evaluation protocols map active molecule densities, locking in the ideal harvesting period and micro-climate provenance.
Development and validation of robust HPLC, UPLC-QTOF-MS, GC-MS, and High-Performance Thin-Layer Chromatography (HPTLC) methods compliant with USP, Ph. Eur., and ChP, guaranteeing unequivocal marker identity and impurity limits.
Pilot-scale parameter modeling for dynamic countercurrent solid-liquid extraction, membrane clarification, macroporous resin adsorption, nanofiltration, and low-temperature vacuum crystallization to retain heat-sensitive chemical structures.
Solving the classical limitations of botanical actives: low water solubility, bitter organoleptic profile, and poor GI permeability. We engineer microencapsulation, liposomal delivery, solid dispersions, and spray-dried direct compression formulations.
Comprehensive safety dossiers meeting OECD guidelines: Acute oral toxicity (LD50), 28-day/90-day sub-chronic repeated dose studies, bacterial reverse mutation (Ames test), in vitro mammalian chromosomal aberration, and in vivo erythrocyte micronucleus testing.
Elucidating cellular signaling pathways (NF-κB, MAPK, AMPK, Nrf2) using real-time PCR, Western blot, and confocal fluorescence microscopy to confirm molecular targets in metabolic disease, chronic inflammation, neuroprotection, and oncology models.
Validation across validated phenotype disease models (rodents, non-human primates): high-fat diet metabolic syndromes, streptozotocin diabetic models, collagen-induced arthritis, DSS-induced colitis, and behavioral neurological testing with pharmacokinetic profiling.
Conducting rigorous GCP-compliant randomized, double-blind, placebo-controlled human trials. Partnered with 30+ top tier Chinese tertiary teaching hospitals to generate submission-grade clinical endpoints for NDA and medical food submissions.
Modernizing ancient TCM multi-botanical synergy through network pharmacology. We model compound-target-disease interaction networks to formulate multi-ingredient botanicals that deliver superior therapeutic efficacy with reduced side-effects.
Commercial-scale API and active botanical manufacturing. Supplied as highly standardized extract powders, concentrated liquids, lipid matrices, and cold-pressed volatile terpenes under clean-room cGMP manufacturing conditions.
Custom packaging and turnkey commercial production of solid tablets, two-piece hard gelatin/HPMC capsules, liquid-fill softgels, effervescent granules, functional shots, and oral suspensions with stability dossiers for multi-zone ICH climatic chambers.
Clear deliverables at every phase, guaranteeing predictability, IP protection, and seamless regulatory clearances.
Plant identity confirmed via ITS2 and psbA-trnH DNA barcoding, ensuring 0% adulteration. Terroir verification across wild-crafted or GAP agricultural plantations establishes seasonal potency baselines.
Target phytochemicals isolated using centrifugal partition chromatography (CPC). Reference standards isolated, HPLC/UPLC analytical methods validated, and chemical stability tested under stress conditions.
Pilot batch runs (100L - 1000L) define critical process parameters (CPPs). Optimization of mass balance, solvent recycling ratios, and residue elimination ensures sustainable cost economics.
Generation of comprehensive GLP-certified toxicology reports. Cellular pathways and target receptor affinities proven to defend label claims and meet FDA/EMA novel food dossiers.
Phase I-IV institutional hospital clinical studies deliver primary and secondary statistical endpoints, safety tolerances, and absorption-distribution-metabolism-excretion (ADME) data.
Multi-ton commercial delivery in clean-room cGMP facilities. Supplied with complete documentation: Certificate of Analysis (COA), TSE/BSE declarations, allergen reports, and stability files.
Our rigorous compliance frameworks bridge Chinese botanical biodiversity with the world’s strictest healthcare regulatory regimes.
Every botanical active is engineered to comply with target international monographs: United States Pharmacopeia (USP-NF), European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), and Chinese Pharmacopoeia (ChP). We systematically quantify heavy metals (ICP-MS), pesticide residues (over 450 compounds screened via LC-MS/MS), aflatoxins, and microbiological counts.
Operating on an entrusted contract research and manufacturing model under strict non-disclosure agreements (NDAs), we safeguard client formulation formulas, process parameters, and cellular screening outputs. Client IP remains 100% proprietary, separated in secure project data silos with isolated pilot production suites.
From our main research facility in Changsha, Hunan, to our collaborative regulatory agencies worldwide, we offer on-the-ground support for customs clearance, specialized phytosanitary documentation, CITES export declarations, and DMF (Drug Master File) filings with international health authorities.
Our translational research infrastructure powers the formulation standards of 33 world-renowned institutions, listed pharmaceutical groups, and university clinical hospitals.
Tongrentang Group
CR Sanjiu Medical
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi River Pharma
Beihai Gofar
Humanwell Healthcare
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharma
Zhongsheng Pharma
Brilliance & Abundance
Apeloa Pharma
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Santo Pharma
Kangshou Pharma
Juwang Pharma
Beijing Tcmages
Ruihe Pharma
CR Jinchan
Kangmei Pharma
Tianjicaotang
Kingstone Unite
Shuguang Hospital
Hunan TCM Hospital
First Hospital of HUN TCM
Second Xiangya Hospital
Second Hospital of HUN TCM
Zhuzhou Orthopedics TCM
Clear, verifiable answers regarding analytical methods, batch reproducibility, regulatory filings, and intellectual property.
Accelerate your life science product timeline with our pre-validated active compound matrices and clinical research workflows.
Whether you are formulating a blockbuster dietary supplement, substantiating European regulatory dossiers, or isolating active novel entities for clinical development, our scientific staff is ready to evaluate your brief.