The Situation

A small European biotechnology start-up company developing a novel approach in the treatment of serious ophthalmic diseases needed support with their first FDA filing for a combination therapy (biologic + medical device) to initiate a Phase 2 trial in the U.S. They provided EVERSANA a tight time frame; dealing at the same time with technical issues that were slowing down the process. It seemed an impossible task.

The Solution

• EVERSANA quickly set up a team to provide the manpower and expertise needed for this submission, from gathering initial data to writing, publishing and submitting the application.
• The team acted as an extension of the client’s team. Due to limited resources available at a small start-up, EVERSANA acted as their regulatory and quality departments, coordinating with client management and their contract vendors in order to increase process efficiencies and develop and assemble the necessary documentation.
• The team routinely exercised creativity and strategic thinking to help navigate the complexities of development and associated technical issues and setbacks.

The Results

• The application was submitted on time, which delighted the client because there was no disruption in achieving their organizational objectives.
• The FDA granted permission to proceed with the study due to the fact that a comprehensive filing was submitted that did not raise any potential clinical hold questions with the IND.