TradeStone QA
Quality Assurance & Regulatory consulting for CROs, IRBs, device and drug companies
About
Provide BIMO Quality Assurance & Regulatory consulting for CROs, IRBs, Drug, and Device companies conducting IND,NDA, 510K, IDE, PMA clinical trials. Conduct mock FDA GCP clinical site audits, vendor qualification, data-management systems audits and medical device QSIT audits (including aseptic processing). 21 CFR Part 11 compliance of your IT system and equipment validation review (Biologics, Biotechnology, Drugs, & Devices). Mock FDA audits of API & sterile biotechnology/ pharmaceutical cGMP.