Challenge

由于监管机构今后将要求以电子格式进行提交,因此提交文件发布的费用可能会让人难以承受,成本很高。各个市场不断变化的监管要求和强制命令使得维持合规性变得越来越困难。With several investigational drug applications (INDs) to the FDA to prepare, Advaxis was seeking experienced and responsive experts to provide and perform compilation, quality assurance, and management of electronic regulatory submissions in compliance with electronic common technical document (eCTD) formatting services.

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Solution

Since February 2015, Advaxis has engaged in a Drug Lifecycle Management agreement with Certara to support eCTD submissions to health authorities. With the support of Certara regulatory operations specialists, Advaxis has maintained six IND applications. Together, the teams prepared lifecycle maintenance submissions for protocol amendments, safety reporting, and annual reports. By utilizing Certara’s regulatory publishing services and submission management, Advaxis has been able to ensure efficient, timely submissions that mitigate the risk of errors and costly delays.

“I have been extremely happy with the Certara-Synchrogenix/Advaxis relationship since September 2015, when I came onboard as an Advaxis employee. I have nothing but great things to say about the professionalism, expertise, and great advice on projects, efficiency in getting submissions out the door in the 11th hour, confidence and staff’s sense of humor when dealing with me. All of you ROCK!!.”

Elizabeth Petroski | Associate Director, Regulatory Affairs Operations ADVAXIS, INC.

Certara ensures efficient, timely submissions through our GlobalSubmit eCTD software and team of regulatory operations and eCTD publishing specialists. Custom partnership models that range from eCTD software solutions for submission management to full-fledged regulatory operations support are available to add capabilities and capacity for our clients.

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