Document preparation and submissions are critical to bringing your product to market. Documentation of clinical processes and preparing the essential paperwork for timely submission can open doors to expediting the approval process.

• Strategy and guidance for FDA meeting requests, briefing packages, preparation and attendance
• Author, review and publish original applications, amendments and supplements
• Prepare or assist in the preparation of regulatory submissions including medical devices, 510(k)s, PMAs, IDEs, de-novo and Pre-Submissions