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 non-­sterile Drug Products. Provide technical support for FDA ­required 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.