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Regulatory Consulting

Category
Data Factory
Description
FDA regulatory strategy, 510(k) submission support, SaMD classification, and clinical data governance consulting for medtech and life sciences companies.
Estimated duration
Project-based
Order
1
Parent
Free Consult
Pricing
$100/hr
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