SEARCH LESS KNOW MORE

The essential FDA Regulatory data and analysis tool for Tanvex BioPharma

STAY FOCUSED ON MAKING BIOPHARMACEUTICALS MORE ACCESSIBLE.

Leave the difficult FDA regulatory analysis and time-consuming monitoring to us.

TANVEX BIOPHARMA SITE PROFILES

SEE THE COMPLETE PICTURE

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

Tanvex 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.

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

Vice President,
RESEARCH & DEVELOPMENT

SHOULD USE FDAZILLA TO:

  • Pull a quarterly report of how Tanvex compared to its peers, so that they can see if they are getting better or worse
  • Supplement rules and guidance with actual field data from enforcement with the Barb Report to improve its training and quality systems updates

CHALLENGE

Too much information with little to no synthesis.

SOLUTION

If a site has been inspected by the FDA, FDAzilla has all the relevant information you need in one place.  Run a Barb Report to see data turn into trend reports you can act on.

CHALLENGE

More complexity to international regulations and more activist inspectors.

SOLUTION

Know exactly what inspectors in specific regions are doing with FDAzilla trend and benchmark reports.

Senior Manager,
Quality ASSURANCE

SHOULD USE FDAZILLA TO:

  • Do Data Integrity training for the team complete with Enforcement Actions (observations/ warning letters) to supplement the regulations
  • Create and run own metrics about what the FDA is really citing 
  • Run a 483 observation report and keyword analysis on warning letters to pull out key trends and do trainings for the internal team

CHALLENGE

Have anecdotes, not solid statistics, which leads to not getting listened to enough by the internal business.

SOLUTION

Gain the confidence and credibility that access to the world’s largest and most complete database of FDA inspection data has to give.

FEATURED CUSTOMERS