Introduction

There’s a lot of knowledge in the world of therapeutics development. While regulatory processes are meant to be entirely transparent, and an incredible amount of information is freely available online, regulatory is still both highly complex, and highly impactful to your business. Specialization and importance often mean consultants, especially for smaller companies that can’t afford to hire regulatory experts.

What

The ideal consultant isn’t one consultant, because your product is multifaceted. Consultants should have copious experience with(in) FDA, in the indication and modality in question. A single expert is unlikely to be able to be sufficiently deep in all aspects of 10 preclinical and clinical development. Determine where your risks are (e.g. CMC and clinical design), then ensure that your consultants can provide first-hand guidance.

When

We would suggest a few hours early in the development process to check your assumptions, then whenever you have serious regulatory questions, and whenever you’re preparing for a meeting with FDA.

Why

Getting positive feedback from FDA is a value driver for your business. Getting negative feedback from FDA has been the end of many businesses. Getting it right is therefore paramount!

Learning Goals

What to look for in your regulatory team.