Regulatory Resources
Pre-Submission Checklist
How do I know if I’m actually ready to talk to the FDA?
This checklist turns that gut feeling into a quick self-test. A short series of pointed questions helps you see whether a Pre-Sub now will generate useful feedback or simply confirm you are still missing critical pieces.
Example Investor Slides
What do investors expect to know about Regulatory?
This template gives you a clear baseline: the minimum you should be able to explain on pathway, evidence, and QMS, and how to go beyond that with best-practice slides that make your regulatory story an asset instead of a weak spot.
Regulatory Due Diligence
What do investors look for in your Regulatory Plan?
Review our Deep Diligence to view the details top investors look for to ensure your device can be made, marketed and manufactured appropriately.
Our Regulatory Process
We know every month counts when you're burning through runway.
Our processes are streamlined to minimize delays and speed up your path to FDA clearance
Pathway memo covering predicate fit, indications, risk/benefit rationale, and evidence plan.
⏱️ 2–3 weeks
Regulatory Assesment
Technical file & test gap assessment; prioritized remediation plan with owners and timelines.
⏱️ 2–3 weeks
Gap Analysis
Draft package; reviewer question map; meeting prep & rehearsal; alignment on evidence sufficiency.
⏱️ ≈3 weeks + ~70 days FDA review
Pre-Submissions
Structured 510(k) dossier; RTA pre‑check; interactive review support.
⏱️ ≈2–3 months + ~180 days FDA review
Submission
No matter where you are in development, we match our support to your current stage so its always right-sized
Where Do We Start?
Apsis Consulting Group
Tel. 475-237-7994
54 State Street, STE 804 #8573
Albany, New York 12207