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U.S. FDA awards LORENZ eCTD Contract

Factorytalk are pleased to announce that our partner LORENZ have been awarded a contract with U.S. Food and Drug Administration (FDA) for “Electronic Common Technical Document (eCTD) Validation and Review Software” on September 30, 2016.

LORENZ will implement the docuBridge, eValidator and Automator solutions in U.S. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) electronic submission programs. CDER and CBER will use the LORENZ product suite to validate and review incoming and legacy eCTD submissions.

Factorytalk are an official LORENZ sales and implementation partner working with South East Asia industry and regulatory agencies.