FDA Regulatory Consulting
Pre-Submission Engagement & Classification
We work with your team to determine the classification of their product (Class II vs. De-Novo vs. Class III) and whether combination products are drug or device led, as per the Request for Designation process.
Early engagement with the FDA often allows you to establish a collaborative relationship with the agency and substantially reduce your time to market. We are experts at negotiating with the FDA to identify the most efficient regulatory path. We can also identify whether a pre-submission meeting is necessary given your situation and any items of risk in your development program that should be discussed with the FDA.
Regulatory Submissions510(k), PMAs, HDEs, IDEs
We have drafted dozens of successful submissions across several therapeutic areas. Our technical background enables us to work your engineering team to identify and fill gaps while ensuring test reports or plans, software, electrical safety data, biocompatibility data, and all other aspects of your submission are in line with FDA expectations. Our aim is to reduce the number of review questions and produce a faster time to market. We supplement our team with an extensive network of experts in biostatistics, toxicology, and clinical sciences who have experience negotiating complex issues with the FDA.