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

TradeStone QA, LLC.

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United States
Austin, TX
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 detailed 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

04/29/2024

https://www.clinicalleader.com/doc/what-to-expect-from-an-fda-inspection-0001

Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.

Address

Austin, TX

Opening Hours

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

Telephone

+12103797358

Website

http://www.tradestoneqa.com/

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