Select a Region North America



Client Success Story

the situation

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

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 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.

• Application submitted in stipulated time.
• A comprehensive filing submitted that did not raise any potential clinical hold questions with the IND.

Contact Us

Results Matter.

Ask us how we can help you achieve process excellence.

Contact Form

  • This field is for validation purposes and should be left unchanged.