Marketing Application Submission Services
Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.
Our expert team of biostatisticians, medical writers, project managers, and regulatory professionals apply best practices from decades of submissions experience to collaborate with our sponsors in the development of a customized application strategy.
YOUR PARTNER FOR STRATEGIC PLANNING & EXECUTION
During the planning stages, we develop innovative approaches to reduce project costs and application timelines. Once the strategy is adopted, our primary goal is to produce a high-quality, fully compliant application structured to expedite reviews by the regulatory agency. All of our submissions have been accepted for filing.