Precision contract research programs delivering high yield, standardized potency, and full regulatory traceability from raw biomass to commercial dosage forms.
Over 14+ years, MedGence (Yineng Pharma) has operated at the intersection of classical ethnomedical wisdom and rigorous modern chromatography. As pharmaceutical companies, dietary supplement manufacturers, and cosmeceutical formulators pivot away from unstandardized crude herbs, the contract research landscape demands high-fidelity chemical quantification, verified biological mechanisms, and seamless tech-transfer to cGMP production.
Phytochemical concentrations fluctuate drastically based on microclimates, harvesting periods, and altitude. Through extensive seasonal and geographical evaluation databases, we decouple commercial botanical production from raw agricultural variance, securing stable bioequivalence.
Natural extracts often present complex synergy or potential off-target toxicities. Our combined pipeline of in vitro cytotoxicity arrays, organoid models, and GLP-compliant in vivo safety panels (LD50, acute, sub-chronic, Ames) builds dossiers ready for FDA, EMA, or NMPA scrutiny.
Contract research without execution guarantees downstream failure. Our dedicated pilot plants and strictly managed commercial CDMO sites preserve high-value molecular structures across extraction, membrane filtration, crystallization, and finished formulation packaging.
Global therapeutics and high-tier nutraceuticals face heightened regulatory enforcement, including the US Botanical Drug Guidance, EU Traditional Herbal Medicinal Products Directive (THMPD), and China’s updated NMPA Traditional Chinese Medicine (TCM) registration pathways.
Moving beyond generic food-grade extracts. Industrializing supercritical CO₂, resin adsorption, and continuous countercurrent extraction ensuring impurity control (heavy metals, polycyclic aromatic hydrocarbons, pesticide residues).
Eliminating inert botanical bulk. We isolate alkaloids, polyphenols, polysaccharides, and saponins down to the specific fraction delivering the therapeutic outcome, reducing required unit doses and improving clinical patient compliance.
Multi-compound HPLC and GC-MS chromatographic fingerprinting ensures that every single manufactured lot matches the reference biological profile, safeguarding global brands from regulatory recalls and efficacy discrepancies.
Entrusted contract research strictly protected under airtight non-disclosure agreements (NDAs). Proprietary extraction parameters and formulation architecture remain your exclusive intellectual property across all target jurisdictions.
Navigating complex international botanical compliance requires hyper-localized scientific documentation. Our regulatory affairs team structures comprehensive technical dossiers harmonized with your target commercial territories.
Comprehensive New Dietary Ingredient (NDI) notifications, GRAS (Generally Recognized as Safe) scientific dossiers, and Investigational New Drug (IND) Chemistry, Manufacturing, and Controls (CMC) technical files aligned with FDA Botanical Guidance.
Dossier preparation under the Traditional Herbal Medicinal Products Directive (Directive 2004/24/EC) and Novel Food application support (Regulation EU 2015/2283), detailing non-clinical genotoxicity and analytical standardization against European Pharmacopoeia (Ph. Eur.) monographs.
Direct authorization support for hospital preparation registrations (56 completed approvals) and modernized classic Chinese medicine compound formulas under the simplified registration pathway for ancient classical prescriptions.
From pure bioactive API compounds to finished shelf-ready packaging, our facilities process complex natural matrices into exact, bioavailable client specifications.
Substantiated structure-function claims supported by small-group human trials. Available formats include microencapsulated powders, dispersible granules, softgel suspensions, and high-clarity oral liquids engineered for gastrointestinal absorption.
Targeting high-burden metabolic, inflammatory, and oncological pathways. Supported by full Phase I, Phase II, Phase III, and Phase IV GCP-compliant clinical trials, pharmacokinetic profiling, and hospital institutional review board (IRB) management.
Skin-penetrating botanical actives with documented anti-inflammatory, antioxidant, and barrier-repair efficacy. Formulated as volatile oils, standardized pastes, and deodorized botanical extracts with proven in vitro human dermal safety.
How MedGence integrates deep-learning predictive pharmacology, molecular docking, and automated continuous bioprocessing into contract herbal medicine research.
Using machine learning algorithms to screen hundreds of thousands of historical botanical chromatographic profiles against receptor targets, cutting early discovery cycles from months to days.
Deploying high-resolution LC-QTOF-MS metabolomics to map multi-target component interactions and synergetic network pharmacology of multi-herb complex TCM formulations.
Replacing conventional batch vessels with automated micro-channel reactors and continuous counter-current membrane extraction, achieving higher yields and minimal heat degradation of thermolabile actives.
Integrating real-world evidence (RWE) tracking and smart wearable bio-sensors for Phase IV clinical surveillance and post-market consumer efficacy verification.
Over a decade of trusted collaboration with tier-one pharmaceutical corporations, healthcare conglomerates, and provincial university medical centers.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi River Pharma
Humanwell Group
Apeloa Pharma
Shuguang Hospital
Second Xiangya Hospital
First Hospital Hunan TCM
Key scientific, logistical, and IP protection inquiries addressed for R&D directors, procurement leaders, and regulatory managers.
Connect with our scientists to order validation studies, pilot extraction batches, or full-scale commercial manufacturing.
