Regulatory Strategy and Submission
When should I bring in a Regulatory Strategist?
The sooner we map your pathway, the fewer detours later.
​
Early engagement lets us align design forks with the least-burdensome FDA pathway—saving months and eliminating surprise bench or clinical tests.
How much does a Regulatory Consultant Cost?
We scope a fixed-price plan after a free discovery call. Whether its a Regulatory Strategy, Pre-Submission, or a Full Submission we give you a Fixed-Price.
​
No hourly creep—investors love the budget clarity.
Am I ready to submit my marketing submission to the FDA?
Our gap analysis benchmarks your data set against successful predicates.
You’ll get a punch-list of missing tests, timeline, and cost.
​
Once every box is green, we draft the submission—zero guesswork, zero panic.
Lean Quality Systems
How lean can our QMS be?
We implement a core set of ISO 13485 SOPs and records—just enough to satisfy auditors while keeping iteration fast.
​
As you add products, the system expands seamlessly without a paperwork explosion.
How long does it take to reach ISO 13485 readiness?
Most early-stage teams are audit-ready within four to six weeks.
​
We deliver a turnkey SOP kit, spin up a Notion-based document-control hub, train your team, and run an internal audit so you pass your first external assessment with confidence.
We don’t need a full-time Quality Manage...what are our options?
Tap a fractional Quality Lead for 5–15 hours a month.
​
You get senior oversight, a live KPI dashboard for investors, and on-call support during audits. When you decide to hire in-house, we recruit and hand over a mature, compliant system.
Fractional QA/RA Leadership
Do we really need a full-time RA/QA hire?
Not at seed or Series A.
Our fractional model gives you senior regulatory and quality oversight 5–25 hours per month—delivering the expertise you need while keeping head-count and equity dilution to zero.
What deliverables do we get each month?
Board-ready KPI dashboard, live issue log, and on-call guidance for design controls, risk files, and FDA correspondence—so investors and auditors see a tight, transparent program.
How does fractional support scale with growth?
Hours flex up or down as milestones shift; when you’re ready for an internal team, we recruit & hand off our processes—ensuring continuity and zero compliance gaps.