Regulatory & Quality Consulting

I Learned How FDA
Makes Decisions.
Then I Spent 20 Years Using That.

20+ years leading RA/QA in industry — managing submissions, building quality systems, and preparing companies for FDA. Victoria brings that experience to every engagement.

Ask Drua's AI — Free Expert Review Services Drua QMS
Former FDA Investigator · 20+ Years Experience · 510(k) · PMA · De Novo · ISO 13485 · EU MDR
20+
Years of Government
& Industry Experience
3
Advanced Degrees Including
Regulatory Science, JHU
FDA
Former FDA Investigator
Los Angeles District
Intl.
Global Regulatory Reach
FDA · EU MDR · Health Canada
How Drua Works

Three Ways to Work
with Drua

Whether you need quick AI-powered answers, a full expert review, or a validated QMS — Drua has a path for every stage of your regulatory journey.

01
AI Assistant · Free to Try
Chat with Drua

Ask anything about 510(k), PMA, De Novo, ISO 13485, or EU MDR. Get instant, expert-calibrated answers — and generate submission templates on demand. First 3 questions free, no account needed.

Start for Free
02
Expert Review · Fixed Scope
Direct Review by Victoria

Have a former FDA investigator personally review your 510(k), PMA, De Novo, ISO 13485 system, or EU MDR Technical File. Fixed-scope engagements from $1,000 — know exactly what you're getting.

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03
Software · Early Access
Drua QMS

A fully validated, inspection-ready quality management system — built by a former FDA investigator around what FDA actually looks for. 20 modules. IQ/OQ/PQ documentation included. Join the waitlist.

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Victoria Nadershahi — Former FDA Investigator, Founder of Drua Consulting
About Victoria

An FDA Insider's Understanding.
20 Years of Industry Results.

Working at the FDA gave Victoria a rare insider understanding of how regulatory decisions are made — not just what the regulations say. She brought that insight into 20+ years of leading RA/QA in industry, managing FDA submissions and quality systems at the VP level. That combination is what she now brings to every client engagement.

Former FDA Investigator M.S. Regulatory Science — JHU MBA — USC 510(k) · PMA · De Novo ISO 13485 EU MDR ISO 14971 Bilingual EN / RU
Read Victoria's Full Bio →
Client Experience

What Clients Say

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"[Client quote about Victoria's FDA insider knowledge helping them get their 510(k) cleared faster or avoid a deficiency letter — ask a past client for a one-paragraph quote.]"

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[Client Name]
[Title · Company]

"[Client quote about the value of working with someone who actually reviewed submissions at FDA — and what that meant for their submission quality or strategy.]"

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[Client Name]
[Title · Company]

"[Client quote about the chat tool, the QMS, or the direct review service — whichever best represents a real client outcome.]"

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[Client Name]
[Title · Company]

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What Would an FDA Investigator
Catch in Your Submission?

Find out before FDA does. Ask Drua's AI free — or have Victoria review your submission directly.

Try the AI — First 3 Questions Free Contact Victoria