Solving the most complex regulatory challenges for combination therapies
A small European biotechnology start-up company developing a novel approach in the treatment of major ophthalmic diseases needed support with their first FDA filing for a combination therapy (biologic + medical device) launching in the U.S. They provided EVERSANA a tight timeframe; dealing at the same time with technical issues that were slowing down the process. It seemed an impossible task.
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 through the complexities of development and associated technical issues and setbacks.
On-time submission of the application which delighted the client because there was no disruption in achieving their organizational objectives.
Permission from FDA to proceed with the study due to the fact that a comprehensive filing was submitted which did not raise any potential clinical hold questions with the IND.