• Mission Statement

    Serve the global public by protecting the supply and quality of healthcare products before entering the market place.

TradeStone QA, LLC

Provide mock regulatory CGMP manufacturing & Quality Assurance inspections, Regulatory consulting for Contract Manufacturing Organizations, Sponsor / Innovator, and Generic drug companies. Aseptic pharmaceutical manufacturing mock FDA, Quality Systems and cGMP Inspections. Manufacturing & laboratory site audits, Component supplier / product vendor qualification, data management systems audits, 21 CFR Part 11 compliance, and validation review. Active pharmaceutical ingredient sterile and non­sterile Drug Products. Provide technical support for FDA­required compliance strategies, including employee training, GMP compliance remediation including Change control implementation & documentation, and Compliance Response to FDA observations. Providing training and presentations to pharmaceutical manufacturers.


Meet Our President

Patrick Stone

Patrick Stone

Patrick D. Stone, M.S. is an ex-FDA, International Inspection Cadre for Bioresearch monitoring (BIMO) and Drugs. Now president of TradeStone QA. Mr. Stone has 12 years experience as a BIMO monitor for FDA. Mr. Stone conducted domestic and international inspections of Clinical Investigators for pre-approval of Biologics/Drugs/Devices, Bioequivalence, IRB and Drug manufacturing.