• Anticipate questions from regulators
• Obtain independent statistical regulatory reviews of meeting documents and study-related documents
• Define study endpoints (including patient-reported outcomes) and analyses that are acceptable to regulators
• Seek guidance on trial design and analyses

• Obtain an independent statistical regulatory evaluation and interpretation of clinical study results
• Stay focused on key topics at your regulatory meetings and advisory committee meetings
• Glean regulatory insights from a highly qualified ex-FDA Master Reviewer

Then we are here to guide you.  Upfront preparation leads to the best possible regulatory submissions, fewer review cycles and, ultimately, getting safe and effective drugs to patients as early as possible.  And that’s what we aim to do.