ODM Clinic Study (Phase 1 - Phase 4)
GCP-compliant clinical evaluation for botanical drugs & dietary nutraceutical registrations.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, SuppliersDirectly engage our specialized research pipelines to bridge empirical botanical ethnopharmacology with stringent global regulatory standards (FDA NDIN, EMA HMPC, and NMPA).
GCP-compliant clinical evaluation for botanical drugs & dietary nutraceutical registrations.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
HPLC, HPTLC, and chromatographic fingerprinting to secure batch-to-batch consistency.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
High-throughput multi-target cellular testing, receptor-binding assays, and bio-activity mapping.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Geographical and harvest-window quantification to maximize target phytochemical yields.
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
Pharmacokinetic, metabolic, and GLP-aligned animal modeling for preclinical clearance.
OEM Animal study Supplier, Suppliers
Targeted isolation of alkaloids, saponins, polyphenols, and bioactive polysaccharides.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Pilot-to-commercial scale process optimization, solvent recovery, and purity enhancement.
Active Ingredient Process Development Suppliers
Full-spectrum formulation into softgels, oral liquids, tablets, capsules, and granules.
Contract Finished Formulation CDMO ServicesThe global herbal medicine, phytopharmaceutical, and botanical dietary supplement landscape is experiencing an epochal transformation. Valued at over USD 160 billion globally, the industry is pivoting abruptly from conventional, empirical botanical formulations toward evidence-based, chemically quantified, and clinically defensible therapeutics. However, pharmaceutical and nutraceutical innovators encounter acute pain points: chemical complexity across multi-component extracts, raw material batch variations driven by geography and climate, complex molecular synergies, and escalating regulatory scrutiny from agencies such as the US FDA (Botanical Drug Guidance), the European Medicines Agency (EMA HMPC monographs), and China's NMPA.
This shifting paradigm has given rise to the specialized Herbal Medicine Contract Research Organization (CRO) and Contract Development & Manufacturing Organization (CDMO). Unlike traditional chemical synthetic CROs that rely heavily on single-molecule high-throughput synthesis, a specialized Botanical Medicine CRO requires specialized mastery over chemotaxonomy, secondary metabolite fractionation, network pharmacology, chromatographic fingerprint stability, and poly-herbal pharmacokinetics. As standard synthetic new chemical entity (NCE) pipelines face elevated attrition rates and exorbitant development costs, biopharma brands increasingly harness natural scaffolds as proven therapeutic platforms for metabolic diseases, chronic inflammation, neurodegenerative decline, and immune homeostasis.
The modern marketplace no longer rewards crude, unstandardized botanical decoctions. Global brands must demonstrate exact Mechanism of Action (MoA), identify precise Reference Chemical Standards (RCS), guarantee heavy-metal and pesticide depletion below strict thresholds (USP <561> / EP 2.8.13), and validate efficacy via randomized double-blind placebo-controlled human trials. MedGence (Yineng Pharma) operates as the primary technological backbone facilitating this global transition.
We deliver modular, vertically integrated contract research suites designed to derisk development, eliminate cross-vendor transfer friction, and safeguard trade secrets.
Target identification across complex secondary metabolomes. We isolate, identify, and quantify saponins, flavonoids, alkaloids, terpenes, and polysaccharides using ultra-sensitive spectral separation.
Explore Screening Platform →Quantifying botanical active concentrations across distinct climatic regions (Dao-di geo-authenticity), specific harvest seasons, and exact plant anatomical parts to lock in maximum raw compound density.
Evaluation Services →Developing and validating analytical monographs (HPLC-DAD/MS, GC-MS, HPTLC, and Q-marker fingerprinting). Establishing quantitative specs for identity, assay purity, stability, and adulterant screening.
Method Validation →Optimizing multi-stage counter-current extraction, supercritical CO2 fractionation, macroporous resin purification, and low-temperature spray/freeze drying for optimal commercial yields.
Engineering Details →Systematic bio-evaluation including cellular viability, antioxidant/anti-inflammatory pathways, rodent animal models, alongside acute toxicity (LD50), 90-day sub-chronic, Ames, and chromosomal aberration assays.
Preclinical Suite →Managing investigator selection, ethical approvals, patient recruitment, and statistical analyses for Phase I–IV trials, matched with flexible cGMP OEM/CDMO production across all standard solid and liquid dosage forms.
Clinical Protocols →Navigating the divergent regulatory frameworks of premier commercial territories requires hyper-localized scientific documentation and dosage engineering.
FDA DSHEA (NDIN / GRAS), Health Canada NPN
Application: Fast-acting cognitive enhancement (nootropics), botanical sports recovery, and microbiome metabolic modulators.
CRO Deliverables: Establishing identity verification via HPLC/HPTLC orthogonal testing, safety toxicological packages for NDI notifications, and clinical biomarker tracking for FTC/FDA structural-function claim substantiation.
EMA HMPC Monographs, EFSA Novel Foods
Application: Traditional Herbal Medicinal Products (THMPD) for anxiety, adaptogenic longevity blends, and standardized cardioprotective therapeutics.
CRO Deliverables: European Pharmacopoeia (Ph. Eur.) compliant analytical profiling, pesticide/PAH/mycotoxin depletion documentation, and bibliographic evidence packages establishing 30-year safe continuous usage history.
NMPA Class 1/3 Natural Drugs, Blue Hat Health Foods
Application: Modernized Classic Famous TCM Prescriptions (83 classic formulas modernized), hospital preparations, and dual-purpose food-herbal wellness formulations.
CRO Deliverables: Classical formula transfer studies, Standard Decoction (标准汤剂) reference correlation, commercial hospital registration (56 filings completed), and full-scale NMPA NDA submission filings.
The convergence of computational biology, artificial intelligence, and automated synthetic green chemistry is defining the next horizon of botanical pharmaceutical intelligence.
Utilizing machine learning and structural molecular docking algorithms to cross-reference multi-component plant extracts against human disease target arrays, predicting synergistic bioactivities before wet-lab synthesis.
Migrating from legacy solvent-heavy batch tanks to closed-loop Simulated Moving Bed (SMB) chromatography and supercritical CO2 extraction, drastically reducing industrial emissions while securing >99% target purity.
Combining digital wearable health metrics and decentralized clinical trial protocols (DCT) to gather real-world human data over extended durations for botanical wellness and preventative longevity products.
Overcoming low natural oral bioavailability through specialized liposomal encapsulation, phytosome complexes, and self-emulsifying drug delivery systems (SEDDS) to elevate physiological absorption tenfold.
Over 14 years of uncompromising laboratory rigor across 300+ scientists, partnering with premier pharmaceutical enterprises and university clinical centers.
Our validated study results and commercial supplies directly power leading publicly traded pharmaceutical organizations, research universities, and Class AAA clinical institutions.
Tongrentang Group
CR Sanjiu Medical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharmaceutical
Golden Throat Holdings
Yangtzi River Pharma
Beihai Gofar Biological
Humanwell Healthcare
SCIMYTH Pharmaceutical
Shandong Hanfang
Luoxin Pharma Group
Zhongsheng Pharma
Hunan Brilliance TCM
Apeloa Pharmaceutical
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Santo Pharmaceutical
Kangshou Pharma
Juwang Pharma Industry
Beijing Tcmages
Guizhou Ruihe Pharma
CR Jinchan Pharma
Kangmei Pharma
Tianjicaotang Pharma
Kingstone Unite Pharma
Shuguang Hospital (Shanghai)
Hunan Provincial TCM Hospital
1st Hosp. of Hunan TCM Univ.
2nd Xiangya Hosp. Central South
2nd Hosp. of Hunan TCM Univ.
Zhuzhou TCM OrthopedicsIn-depth technical and commercial answers addressing regulatory validation, analytical transfer, intellectual property safeguarding, and scale-up engineering.
Select a specific validated research module or initiate high-capacity contract OEM manufacturing through our integrated biopharmaceutical facilities.
Decentralized and hospital-centered clinical trial oversight with biometric verification.
ODM Clinic study (Phase1 - Phase 4） Manufacturer, Suppliers
USP, Ph. Eur., and ChP monograph establishment and assay precision testing.
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
In vitro MoA validation, enzyme inhibition assays, and cellular protection metrics.
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Comparative chemical potency assessments across harvest cycles and microclimates.
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
Efficacy verification in disease-specific rodent models under GLP conditions.
OEM Animal study Supplier, Suppliers
Selective extraction and high-potency isolation of bio-active secondary fractions.
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Commercial supply of standardized extracts in concentrated powders, oils, and liquids.
Request Active Ingredient Specifications
High-speed automated manufacturing of capsules, tablets, and drinkable liquids.
Contact CDMO Engineering Specialists