Ensuring high-quality and efficient submission processes from planning to execution

Our Regulatory Operations Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Team leadership has at least 10 years of experience in electronic publishing and production of eCTD submissions. Team members are trained in report-level publishing using the Lorenz DocuBridge and other submissions platforms, regulatory affairs, submissions project management, and eCTD-related data science.

This group routinely submits ~250 regulatory submissions per year, including multiple full marketing applications and IND submissions along with many serial maintenance submissions for ongoing programs. Additionally, this team handles report-level publishing for the numerous clinical study reports produced each year in support of our clinical trials work.

For every submission project, the lead regulatory operations expert ensures a high-quality and efficient submission process by working closely with the project lead from the initial stages of submission planning to develop and execute a detailed submission filing strategy. This close partnership allows the regulatory operations lead to guide the wider project team and sponsor through the publishing, review, and electronic filing process. As needed, the regulatory operations team also trains sponsor and 3^rd party individuals involved in document generation in best practices for document authoring.