Essenvia

Essenvia is an online platform to streamline regulatory pathway for medical device companies. FDA research data indicates that regulatory submissions have grown in complexity and size with an average of 1185 pages per submission, with a consistent 30% rejected at initial review and 64% sent back for additional information. Essenvia’s regulatory software streamlines the regulatory submission process by improving collaboration and automating some of the most time-consuming and error-prone tasks. Submissions processed on Essenvia reduce time and effort by 40% and eliminate 52% of errors. We are determined to reduce avoidable errors in regulatory submission and help medical device companies accelerate time to market.