ODM Nda Application Manufacturer & Manufacturers

An end-to-end ODM/CDMO partner like MedGence oversees the complete Chemistry, Manufacturing, and Controls (CMC) module. This includes botanical taxonomy verification, raw material potency screening across seasons/geographies, extraction process optimization, chromatographic identification (HPTLC/HPLC/GC), preclinical toxicity evaluation (LD50, Ames, micronucleus), in vitro and in vivo animal efficacy studies, formulation stability testing, and execution of human clinical studies (Phase I through Phase IV).

Yes. Our proprietary pilot plants and affiliated commercial cGMP facilities are directly managed by our internal staff of 300+ research scientists and engineers. This integration prevents knowledge and analytical handover errors between distinct research vendors and manufacturing plants, reducing scale-up timelines while securing reproducible batch-to-batch yield and analytical uniformity.

We employ orthogonal chromatographic separation and spectroscopic identification. This encompasses High-Performance Thin-Layer Chromatography (HPTLC) for holistic visual fingerprint verification, reversed-phase High-Performance Liquid Chromatography (RP-HPLC) coupled with DAD/MS for target active quantification, Gas Chromatography (GC) for volatile components, and chromatographic fingerprinting to detect adulterants and quantify natural chemical variances across production batches.

All collaborative synthesis, screening, and CDMO production take place under legally binding bilateral Non-Disclosure and IP Escrow Agreements enforceable under Chinese and international law. We employ clean-room information zoning where data silos restrict formula composition and technical parameters strictly to project-assigned researchers, completely preventing competitive leakage.

For active pharmaceutical ingredients (APIs) and botanical extracts, we supply concentrated aqueous/ethanolic liquids, spray-dried and vacuum-dried powders, viscous pastes, and steam/supercritical CO2 volatile oils. Finished consumer and clinical dosage forms include oral liquids, softgels, hard gelatin/vegetable capsules, coated tablets, soluble effervescent powders, and standardized pharmaceutical granules.

Yes. We structure both exploratory micro-dose human trials for nutraceutical and cosmetic clients as well as multi-center, double-blind, randomized controlled Phase I, II, III, and IV clinical programs for botanical drug applications (NDAs). Every clinical study complies with ICH Good Clinical Practice (GCP) guidelines, generating auditable eCRF data packs accepted by domestic and global drug review authorities.