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DRUA
Regulatory & Quality Consulting
Shaping the Future of FDA-Regulated Innovation
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Expert Review Services

Work Directly with Victoria

A former FDA investigator reviews your submissions, quality systems, and regulatory documents — giving you an insider's edge before you submit.

FDA
FDA 513(g) Request for Information Review
$1,000 per engagement
FDA
FDA Pre-Submission (Q-Sub) Meeting Package Review
$1,000 per engagement
Quality & QMS
Corrective and Preventive Action (CAPA) System Review
$1,500 per engagement
Quality & QMS
Device History Record (DHR) Review
$1,500 per engagement
Quality & QMS
ISO 13485 QMS Implementation Review
$1,500 per engagement
Quality & QMS
FDA QSR / ISO 13485 Gap Assessment
$3,500 per engagement
FDA
FDA Premarket Notification 510(k) Review
$5,000 per engagement
EU MDR
EU MDR Technical File Review
$8,000 per engagement
FDA
Design History File (DHF) Review
$8,000 per engagement
FDA
FDA De Novo Classification Request Review
$8,000 per engagement
Quality & QMS
Conduct Internal Quality Audit
$10,000 per engagement
FDA
FDA Premarket Approval (PMA) Application Review
$50,000 per engagement

Not Sure Where to Start?

Chat with Drua's AI assistant for guidance, or contact Victoria directly to discuss your specific situation.

Chat with Drua Contact Victoria