At Mederi, we handle regulatory publishing in-house—eliminating the need for additional vendors and ensuring every submission aligns seamlessly with your development timelines. From INDs and amendments to meeting packages, DSURs, and NDAs, we manage the formatting, validation, and submission process with precision and compliance at the forefront.

Our in-house model allows for tighter coordination, fewer handoffs, and faster turnaround times. We work closely with your team to ensure documents are submission-ready, properly referenced, and fully aligned with current regulatory requirements—reducing risk and avoiding last-minute delays.

With deep experience in eCTD structure and FDA submission expectations, we make the publishing process smooth, efficient, and worry-free. By keeping this capability within our core team, Mederi gives you the agility and reliability you need to stay focused on science and development—while we handle the document logistics.