clinical trial material manufacturing

Frontage Laboratories, Inc. is a global pharmaceutical development organization (PDO) and CRO providing integrated, science-driven product development services throughout the drug discovery and development process. It assists clients in advancing molecules through development to commercial launch, enabling innovators, generic, and consumer health companies to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets.

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analytical servicesbioanalysisbiostatisticscentral lab servicescommercial manufacturingDART servicesdata managementDMPKdrug developmentdrug discoveryformulation developmentgenetic toxicologyGMP routine testingmass spectrometrymethod development and validationsafety pharmacologystability programsstatistical programmingtoxicology

Irvine Labs is a Huntington Beach, California-based company established in 1997 that researches and develops natural, botanical drugs and supplements. It is a DEA bulk drug manufacturer, importer and exporter, and a cGMP manufacturer licensed by the FDA for food, supplements, and prescription and OTC drug manufacturing. Its drug candidates are in FDA clinical trials at Phase II or later.

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botanical drug research and developmentbotanical extractioncGMP manufacturingcontract manufacturingDEA bulk drug manufacturing, importing and exportingGood Agricultural Practices (GAP) cultivation