Proprietary natural extract characterization and compliant regulatory execution from raw plant chemistry to finished formulations.
Navigating the transition from traditional phytotherapy to FDA/EMA-compliant botanical drug development through evidence-driven analytical validation.
Unlike single-molecule synthetics, botanical drugs consist of complex, multi-component chemical mixtures where therapeutic efficacy originates from multi-target synergistic mechanisms. Harmonizing this chemical diversity requires high-throughput orthogonal fingerprinting (HPLC-MS, GC-MS, HPTLC) to establish definitive chemical batch-to-batch consistency.
Phytochemical concentrations fluctuate drastically based on geo-authentic origin, soil microbiome, climate variations, and harvest timing. MedGence solves raw material volatility by deploying rigorous origin evaluations across multiple harvest seasons, anchoring downstream industrial extraction on scientifically verified raw materials.
Both the US FDA (Botanical Drug Guidance) and European EMA establish intense thresholds regarding environmental contaminants, residual pesticides, heavy metals, and genotoxicity profiles. We construct verifiable CMC (Chemistry, Manufacturing, and Controls) dossiers that ensure effortless international dossier approvals.
Decades of verified translational research and industrial pipeline deliveries with leading pharmaceutical groups, research hospitals, and global innovators.
De-risking phytochemical candidates across every phase of contract pharmaceutical development.
High-throughput natural molecule characterization, bioactivity profiling, and multi-regional botanical potency assessments across distinct seasonal windows.
Development and validation of robust HPLC, GC, and HPTLC chromatographic assays for active markers and full-spectrum multi-peak identification.
Pretreatment parameter modeling, supercritical/solvent extraction, multi-stage chromatographic resin purification, and spray/vacuum drying scale-up.
GLP-compliant in vitro cellular pathway screening, LD50 assessments, acute and sub-chronic toxicity assays, and in vivo efficacy modeling.
Support for Phase I–IV clinical development protocols, micro-dosing safety studies, followed by cGMP commercial batch manufacturing in dedicated facilities.
Tailoring botanical chemistry dossiers to the exact statutory frameworks of North America, Europe, and Asia-Pacific.
We align botanical CMC packages with the US FDA Botanical Drug Development Guidance. By ensuring full botanical raw material traceability, documented geographic controls, multi-marker quantification, and biological assays, we reduce IND risk and provide full documentation support for botanical prescription therapeutics.
We structure dossiers adhering to the Committee on Herbal Medicinal Products (HMPC) directives, accommodating both Traditional Herbal Medicinal Products (THMPD) and Well-Established Use (WEU) filings. Comprehensive European Pharmacopoeia (Ph. Eur.) compliance is maintained for all heavy metal, residual solvent, and aflatoxin assays.
Bridging the gap between pharmaceutical rigor and consumer dietary supplement claims. We supply standardized full-spectrum powders, granulates, and oil distillates supported by randomized, double-blind in vitro and human pilot data to provide defensible market differentiation.
Powering research initiatives, monographs, and commercial lines for over 100 enterprise clients.
Clear answers on regulatory filings, analytical verification, scale-up, and IP protection.
Select individual study modules or initiate full-program CRO/CDMO integration with our technical board.
Submit your target biological indication, target botanical taxon, or desired dosage form. MedGence's multidisciplinary team will prepare a tailored protocol, timeline, and preliminary analytical scope.