SEARCH LESS KNOW MORE



The essential FDA Regulatory data and analysis tool for Abeona Therapeutics, Inc.

STAY FOCUSED ON FINDING A CURE FOR SERIOUS DISEASES.

Leave the difficult task of evaluating and assessing the risk of potential CMOs to us.

RESEARCH SITES

SEE THE COMPLETE PICTURE

Quickly assess the 483 issue rate of possible CMOs and all of your sites, as well as Warning Letters and aggregated CFR Citations—all in one place.

Abeona Site
Tanvex Keywords

TAGGED & SEARCHABLE DATA 

FOCUS ON THE DATA THAT MATTERS

All in-stock 483s have been retyped and tagged with keywords to help you quickly analyze your data.

Filter searches by industry keywords and site tags.

BENCHMARKS, TRENDS, & REPORTS

ELIMINATE UNWANTED SURPRISES

Benchmark performance relative to your peer group, which creates the business case for preemptive corrective actions.

Be one step ahead of the FDA by determining key areas of focus. 

Align your budget and CAPAs to the top issues and emerging trends.

Abeona Benchmark

INSPECTOR PROFILES

KNOW WHERE TO CONCENTRATE YOUR EFFORTS

Identify the most common issues and focus areas of your inspectors.

Link to all inspections and citation data.

HOW DIFFERENT DEPARTMENTS AND PEOPLE USE FDAZILLA

senior VICE PRESIDENT, REGULATORY AFFAIRS

USES FDAZILLA TO STAY ON TOP OF:

  • CFR Citation Trends
  • Quality Risk Management
  • Annual Inspection Trends
  • Keyword Analysis including CAPA, Data Integrity, Quality Compliance, Risk Management

CHALLENGE

Weeding through too much info

SOLUTION

FDAzilla Macro Trends Report &

Keyword Analysis

CHALLENGE

Tight budgets and not enough people

SOLUTION

FDAzilla Enforcement Analytics

vice president, quality & technical operations

USES FDAZILLA TO STAY ON TOP OF:

  • CFR Citation Trends
  • Annual Inspection Trends
  • Regulatory and Guidance
  • Keyword Analysis including CAPA, Data Integrity, Quality Compliance, Risk Management

CHALLENGE

Trouble getting the right trends


SOLUTION

FDAzilla Macro Trends Report

CHALLENGE

Staying on top of everything

SOLUTION

FDAzilla Monitoring and Alerts,

Benchmarking

DIRECTOR OF QUALITY AND COMPLIANCE

USES FDAZILLA TO STAY ON TOP OF:

  • CFR Citation Trends
  • Annual Inspection Trends
  • 483 Observations
  • Keyword Analysis including CAPA, Data Integrity, Quality Compliance, Regulatory, Guidance, Pharmacovigilance

CHALLENGE

Knowing the right answers

SOLUTION

FDAzilla Macro Trends Report,

483 Observations

CHALLENGE

Staying on top of everything

SOLUTION

FDAzilla Monitoring and Alerts,

Benchmarking

FEATURED CUSTOMERS