What does a typical engagement look like?
A free 30-min consult, a written Statement of Work, and an engagement that runs anywhere from 2 weeks (a Pre-Sub package) to 18 months (a full PMA program with clinical strategy).
Do you work with startups or only large companies?
Both. Roughly 60% of our client base is Series-A to Series-C biotech / medtech. We also have ongoing engagements with Merck, Amgen, and a handful of public-company device manufacturers.
Will you sign an NDA?
Always. We will execute a mutual NDA before any technical discussion of your program.
Can you sit on our QMS as Management Representative / RA Director on a fractional basis?
Yes. We offer fractional QA/RA Director arrangements (typically 4–16 hrs/week) for startups not ready to hire full-time.
Do you handle clinical operations and CRO oversight?
Yes, but as a regulatory partner — we author your Clinical Strategy Document, project-manage your CRO selection, and oversee data integrity. We are not a CRO.