Whether preparing for the end of Phase II meetings (EOP2), filing after Phase III, or drafting a pediatric investigation/study plan (PIP/PSP), these interactions have a short turnaround time despite many stakeholders. Timely regulatory interactions, such as scientific consultations and regulatory matters, are key in the aforementioned matters. Other types of regulatory interactions include the FDA’s MIDD Pilot Program which facilitates integrating MIDD into drug applications and advancing its use.

• We have worked with FDA (US), EMA (EU), PMDA (Japan) and other national agencies, and have consultants with experience from the MPA (Sweden).
• We provide drug development support with comprehensive pharmacometrics analysis reports that serve your entire team and aid with timely regulatory interactions, such as scientific consultations and regulatory matters.

To support decision-making in special populations trials, we can recommend an appropriate platform:

Pharmetheus is an experienced partner offering a reproducible reporting system that provides outsourced analysis, expert advice in the form of review or coaching, and embedded scientist project support. Learn more about the solutions we offer related to regulatory interactions.