Accelerate your submission when timelines are tight
In the long-winding road that is clinical drug development, we know there are moments when speed is of the essence.
Not long ago, we were approached by a sponsor facing an accelerated IND submission deadline. They needed to prepare a large, complex response for the FDA in a matter of days. Failing to meet the deadline could have resulted in a clinical hold and the pausing of their entire development program.
Together we will keep your submission moving
Working in close collaboration with the sponsor, we rapidly assessed the scope of the project. Our advanced publishing tools and expert project management skills enabled us to tackle the workload with speed and accuracy. As a result, within 48 hours of being briefed we had submitted a flawless response, which successfully met the FDA IND submission deadline. The sponsor was clearly delighted, stating:
“Your publishing time is half of what we’ve experienced with other providers.”
Success through flexibility and experience
However, meeting a tight timeline is only part of the story. The thing that made this possible is our extensive experience and flexible operating structure. It means we can quickly adapt and assemble a highly qualified team tailored to meet your specific regulatory needs. Whether you’re preparing and initial IND submission, responding to FDA questions or you need support across your clinical program, we are ready to help.
Keeping your IND submission on the right track
So don’t hang back. Contact eCTD Submit today and together we’ll ensure your program stays compliant, on time and on track.