The goal of every Generic Drug and API manufacturer is to bring product to market as quickly as possible. As soon as a candidate therapy is discovered as having promise, efforts begin to apply for permission to conduct trials. This includes the need to manage all the documentation generated from the research and trials. This need becomes even more acute as clinical trials bear fruit and the organization prepares to file its first NDA or BLA. This necessitates a high degree of collaboration between the sponsor, contract research organization, study teams, doctors, and patients. All of these activities generate documents in the thousands in both electronic and paper formats.
By providing seamless Collaboration across all parties, trials can proceed smoothly and eventually submissions can be prepared and submitted to regulatory agencies. Having an automated document management and collaboration system to manage research documents, protocols, CRFs, study tagging files, and all other documents related to discovery, makes submissions a relatively easier and more efficient process. Establishing a Quality Management Solution in conjunction with an EDMS for Submission Document Management further enhances the solution by providing a unified platform to also manage study site audits, study deviations, and complaints.
Download this webinar on Managing Successful Submissions and US FDA Audits to hear best practice measures that companies need to have in place to mitigate negative inspection results. With the decision of the US FDA not to accept paper based drug submissions from January 1, 2015, this webinar outlines what you need to do when preparing electronic dossiers for the FDA. It highlights best practices to ensuring accurate submission content to significantly reduce agency approval time.
And watch these webinars to learn more about the changes in the regulation of the Generics Industry, and how to address them: