Navigating the regulatory clearance process can be overwhelming. However, the scope of the regulatory challenge needs early determination as it can have a significant impact on the commercialization plan, including the riskiness of the plan, the budget and skill sets required. Clarity in this area if often a prerequisite to attract investment.
Determination of regulatory path.
Determination of test plan.
Implementation of design controls.
To address regulatory challenges we generally take the following steps:
We assess the likely classification of the product and propose a test plan to satisfy the FDA and is cost efficient for the client.
Where appropriate we will prepare for and manage working directly with the FDA to ensure critical issues are addressed and consequences associated with specific product features and indications are understood.
We propose design control procedures which are both practical and comply with FDA requirements. We play a hands on role in applying these procedures so that they are efficient and enhance development speed and quality.