FDA Submissions

The FDA is the drug and device regulatory body for the biggest pharmaceutical market in the world. The FDA does not only play an important role for the United States but also for the development of regulatory requirements globally.

If someone is developing a drug either in the United States or Europe, this person must be sure to take into consideration the requirements of the other market.

As a Europe based organisation our goal is to focus on the commonalities between European and FDA requirements and to remain cognizant of the differences where they could have an influence on drug development.

Together with our clients we prepare, maintain, and execute development and regulatory plans which take into account both the US and the EU specialities. We tailor the plans in a way that the client can decide whether a parallel development leading to a parallel submission is the appropriate choice or if resources and efforts should be concentrated on either the EU or US without neglecting to do the right fundamentals to prepare for a development in the other part of the world as well.

Our services for drug development in the United States include