With proper planning and groundwork, successful submissions do not require last minute scrambles and overtime. Aerie Canal can help you deliver electronic submissions on time, on budget, and with less stress.

The bulk of the work is done during the authoring process. Creating documents from templates, inserting tables correctly, and following company style guidelines are key elements to reducing publishing timelines.

It is the role of Regulatory Operations to lay the foundation for this approach very early in the process and to support authors throughout the entire document development and review process. It is essential to meet with key groups early on to establish standards for every document type and define clear processes for document handoff.

Whether a team is working on a company’s first marketing application, or a line-extension for a blockbuster product, each project is a new challenge that requires matching the team, the technology, and the process to deliver a quality submission.

With the advent of eCTD, smaller companies can now create electronic submissions with minimal overhead. The Electronic Submissions Gateway enables any company to deliver submissions over the web so that FDA reviewers receive them the day they are published. The barriers to entry have never been lower for electronic submissions.