FAQs
Can you support companies before funding is awarded?
1
Yes, part of our goal is to help companies secure the funding needed to support product development efforts.
When should regulatory expertise be incorporated into the product development lifecycle?
2
It is essential to develop a regulatory strategy early on in the product development process. Defining the product intended use, regulatory pathway, and regulatory requirements will guide all downstream development activities.
Which regulatory pathways do you support for IVDs?
3
We support De Novo, 510(k), CLIA Waiver, Dual Study Submission, and EUA Pathways. We can also assist with pre-submissions and responding to FDA requests for additional information.
Do you specialize in specific types of IVDs?
4
Our specialties include IVDs for the detection of infectious diseases. We have experience with molecular, antibody, and antigen-based technologies across all intended use settings (High complexity, Moderate Complexity, CLIA Waived and Home Use).