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.