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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.

Regulatory clearance

  • 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.


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