Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New Jersey.
Challenge
Submission publishing can be prohibitive and costly with regulatory agencies requiring ever more submission types in electronic formats. Changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. 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.
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.
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.
