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Medical Devices / Submissions and Approvals

FDA Grants Lorenz eCTD Contract

Oct. 14, 2016
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The FDA has awarded Lorenz an “Electronic Common Technical Document (eCTD) Validation and Review Software” contract on September 30, 2016, through a competitive procurement process.

The company will implement its docuBridge, eValidator and Automator solutions in CDER and CBER electronic submission programs and they will be used to validate and review incoming and legacy eCTD submissions.

The partnership will commence in October 2016, the company said. — Cynthia Jessup

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