Submissions & Publishing

Our Regulatory Strategy and Submissions 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. Every member of this team 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 3rd party individuals involved in document generation in best practices for document authoring.

Our document publishing and regulatory submission related services, include:

Our Experience

We routinely submit

250

regulatory submissions per year

Every team member has at least

10

years of experience in electronic publishing and production of eCTD submissions

100%

technical acceptance rate

Marketing Application Planning Tool

If you’re interested in working with us on your marketing application, download and complete our planning tool to provide us with critical information about your program.

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