Regulatory Consulting

FDA regulatory strategy, 510(k) submission support, SaMD classification, and clinical data governance consulting for medtech and life sciences companies.

$100/hrProject-based

Book a Free Consult

Regulatory strategy and data analysis for medical device and SaMD (Software as a Medical Device) companies. I combine hands-on FDA submission experience with data engineering to help you navigate the regulatory landscape faster.

Services

Regulatory Strategy

Pathway determination, 510(k), De Novo, PMA, or exempt?
Predicate device identification and comparison
SaMD classification (FDA, IMDRF framework)
Pre-submission (Q-Sub) strategy and preparation

FDA Data Analysis

Complete Response Letter (CRL) analysis, identify common deficiency patterns
510(k) clearance trend analysis for your product category
Adverse event and recall monitoring dashboards
Competitive landscape mapping from public FDA data

Clinical Data & OMOP

OMOP CDM data pipeline design and implementation
Clinical NLP for entity extraction (conditions, medications, procedures)
Real-world evidence (RWE) study design support

Relevant Projects

FDA CRL Analyzer, Analyzed 202 Complete Response Letters across 8 deficiency categories and 7 therapeutic areas
FDA Devices MCP Server, AI-powered tool for querying FDA device classification, 510(k), PMA, recalls, and adverse events
SaMD Clearance Visualization, Interactive D3.js visualization of FDA SaMD/AIaMD clearances
OMOP Entity Extractor, AI-powered clinical text extraction mapped to OMOP CDM
Drug Normalizer, Drug name standardization tool deployed on Vercel

Pricing

Hourly consulting, $100/hour
Regulatory strategy package (pathway + predicate analysis), $300–$600
FDA data analysis project, $500–$1,500
Ongoing advisory, Monthly retainer, scoped to your needs

Schedule a Consultation

Book a free consult and bring your device type, regulatory question, or data challenge. The first 30-minute call is free.

Project-Based

Pre-submission package, Fixed fee covering strategy through Q-Sub meeting preparation, $500–$1,000
Full submission support, End-to-end from regulatory strategy to 510(k)/De Novo submission, $1,500–$2,000
Deliverable-based, Fixed-price report (competitive landscape, CRL patterns, predicate analysis), $300–$800