Challenge

電子データ申請では、非常に多様な形式の申請文書の提出が規制当局より求められるため、文書作成業務に極めて高いリスクと重いコストが発生する恐れがあります。世界各国における規制当局の要件や規定の度重なる変更によって、法令順守体制の維持はますます難度の高い取り組みになっています。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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