Two things set our team apart: our years of experience and history of leadership within the FDA, and our experience in the industry leading teams in product development and clinical studies. This uniquely positions us to help bridge from your world to the FDA’s world. Because we know what FDA is looking for and also understand your reality on the ground, we are best positioned to help you strategize and present your product for a successful regulatory outcome.

We can help you to prepare your submission in one of two ways: We will give you the tools you need to prepare a draft of your submission yourself, and then we will review that draft and offer detailed feedback in order to make it FDA-ready. After all, you know your product better than anyone else. If you would prefer that we write your submission, we can collect information and materials from you and draft your submission for you.

We are experienced in the full range of FDA regulatory submissions, including: • Pre-Submissions (Pre-Sub) • Investigational Device Exemptions (IDE) • Premarket notifications [510(k)] • Dual 510(k)/CLIA Waiver • De Novo pathway • Premarket Approval Applications (PMA) • CLIA waiver applications • Investigational New Drug Applications (IND) • Biologics License Applications (BLA) • Pre-EUA and EUA • Breakthrough Device applications

While we do not actually conduct clinical performance studies (we generally recommend that you work with a reputable Contract Research Organization, or CRO), we still play an important role by reviewing the study protocols before the study begins. This includes assisting with statistical issues, making decisions on the size of studies and the statistical analysis of study data. A member of our staff has extensive experience with study design and data analysis compliant with FDA submission expectations and requirements.

Our team members have participated in FDA inspections while we served at the agency, and have the ability to conduct a mock audit in order to help you minimize the number of issues that might be flagged by the FDA inspector.

Yes, a member of our team can participate in FDA meetings with your company. We prefer to be observers on these calls, rather than facilitators. This allows us to focus on capturing the nuances of any concerns or requests that the agency communicates.

A member of our staff has extensive experience with study design and data analysis compliant with FDA submission expectations and requirements for IVDs.

Our team includes an expert in software validation requirements for the regulation of IVDs.

We can and have served as an expert witness in legal proceedings where our expertise is relevant.

We expect that our clients will identify someone within their organization to serve as the official sponsor and correspondent for the submission. Sponsoring submissions ourselves would interfere with our impartial position as reviewer and assessor. Having you sponsor the submission yourself gives you ultimate control over your decision-making and the timeliness of your responses to FDA communications.

Our expertise is limited to the regulation of IVDs.

No. In addition to restrictions imposed by the non-disclosure agreements we establish, we maintain a strict policy of not sharing who our clients are. We recognize that can reveal proprietary information in this highly competitive space. That, and our strong FDA backgrounds, make us continually conscious of confidentiality.