The iQue ® software module for 21 CFR Part 11 ensures next-level iQue ® productivity for regulated laboratories. Designed for speed and actionable results, iQue ® is the instrument of choice ...

See 21 CFR parts 11, 54, 210, 211, 312; the FDA Center for Drug Evaluation and Research; and UAB HRPP PRO121 Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets ...

SAN DIEGO, CA / ACCESSWIRE / September 17, 2024 / XiltriX North America is the only real-time environmental monitoring ...

Working from the instrument or PC and LabX will ensure that you are fully compliant with regulatory standards such as FDA 21 CFR Part 11. Use the services offered from METTLER TOLEDO for software ...

The Council on Foreign Relations (CFR) is an independent, nonpartisan membership organization, think tank, and publisher dedicated to being a resource for its members, government officials ...

Applications for proposed drug products where the rate (21 CFR 314.54(b)(2)) and/or extent (21 CFR 314.54(b)(1)) of absorption exceed, or are otherwise different from, the 505(j) standards for ...

This post was flagged as part of Meta’s efforts to combat ... of The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b), March 15, 2023 ...

People with obesity who took the highest dose of the drug lost 21 percent of their total body weight, according to a randomized-controlled trial published in the New England Journal of Medicine.

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