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Data Factory

📑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
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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

Email prahlaad@pyaar.co with your device type, regulatory question, or data challenge. 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