TradeStone QA, LLC.

TradeStone QA, LLC. Clinical trials, Drug manufacturing, and Biologics QA consulting.

Provide BIMO Quality Assurance & Regulatory consulting for CROs, IRBs, and drug companies conducting IND,NDA, 510K, IDE, PMA clinical trials and pharmaceutical manufacturing. Conduct GCP clinical site audits, vendor qualification, data management systems audits & qualifications, 21 CFR Part 11 compliance, and validation review. API & sterile Drug Product pharmaceutical cGMP audits and prepare deta

iled report of audit findings. Provide technical support for FDA-required compliance strategies including employee training, protocol adherence, ICF process, and research operation SOP's for clinical trial sites, professional societies, and academia

Address

Austin, TX

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

Telephone

+12103797358

Website

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