Pre-Submission Document Review
The FDA submission requirements can be overwhelming, and missing or unclear information are likely to delay your success. We review your documents before you submit them to ensure they are clear, well-organized, scientifically sound, and contain the information that the FDA is looking for.
Responses to FDA reviews
The feedback you receive from the FDA can be confusing. We can explain not only what the issues are, but why they are issues, and help ensure that your responses address the regulators’ underlying concerns.
Manufacturing facility inspections
We help determine inspection readiness and act as a buffer between you and FDA to maximize the likelihood of success.
A well-designed clinical performance study is crucial to generating acceptable data to support product performance. Conducting a study once is costly enough; we help you get it right the first time.
Interaction with FDA
We can accompany you for in-person and teleconference meetings with the FDA to simplify and clarify discussion points, and ensure you get the most out of each interaction.
Understanding FDA requirements and how the FDA thinks can make a big difference in the effectiveness of not only regulatory personnel, but all employees. We help your staff understand how the FDA thinks – because EVERYONE plays a role in maintaining quality.
Before investing in a product, it's critical to understand its likelihood of regulatory success and regulatory readiness.
Before investing in a company, it's critical to understand its commitment to meeting and maintaining a culture of quality.
Both have a major impact on the likelihood of success and time required to get that product on the market.
Through assessing product design, facility site inspections and staff interviews, we can give you an understanding of that likelihood of success and timeline.
Global Regulatory Bodies
Putting into practice and maintaining an IVD regulatory system can be challenging.
Based on our extensive global health experience, we break down concepts into manageable, understandable pieces to help create effective regulatory systems and competent regulatory professionals.