Rachel Bombara

Sponsor companies are now expected to submit globally as quickly as possible. Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning. The first half of this webcast will cover how to plan for simultaneous global submissions, including aspects the team can control and aspects that are out of the team’s control.

When choosing how to accomplish your IND submission, there can be many elements to the process that must be determined: budget, software, personnel support, and more. To further complicate matters, these components must come together in harmony to ensure a smooth filing.

As the pharmaceutical industry continues to evolve, so too do the processes for regulatory submissions. One significant development is the introduction of eCTD (Electronic Common Technical Document) 4.0 (read this blog to get a primer on eCTD if you’re not familiar with it). This latest iteration promises to overhaul the way pharmaceutical companies submit their drug development data to health authorities.