SEARCH LESS KNOW MORE

The essential FDA Regulatory data and analysis tool for Boiron.

STAY FOCUSED ON GLOBAL LEADERSHIP IN HOMEOPATHIC MEDICINE.

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

RESEARCH SITES

SEE THE COMPLETE PICTURE

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

Boiron Site
AveXis 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.

Boiron Benchmark
Boiron IP

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,
QUALITY AND COMPLIANCE

USES FDAZILLA PRO TO:

  • Pull reports to see how Boiron compares to its peers
  • Supplement rules and guidance with actual enforcement field data to improve training and quality systems

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.  Use the Macro Trend Report to filter and analyze data by keyword, CFR part, and more.

CHALLENGE

Staying on top of regulations and ensuring inspection-readiness.

SOLUTION

Know exactly what inspectors in specific regions are focusing on and citing with FDAzilla Macro Trend Report, Benchmark Report, and Inspector Profiles.

DIRECTOR,
QUALITY CONTROL

USES FDAZILLA PRO TO:

  • Run detailed and specific metrics to know what the FDA is really citing, especially those on similar companies
  • Run a 483 Observation Report to pull key trends by keyword
  • Stay on top of training with thorough enforcement analytics to supplement regulations

CHALLENGE

Knowing the right answers: having statistics, not anecdotes.

SOLUTION

Use the Macro Trend Report to filter and analyze 483s and Warning Letters by keyword, CFR part, and more.

CHALLENGE

Trouble getting the right trends to act on.

SOLUTION

Gain confidence with FDAzilla’s Benchmark Report to know exactly what trends are impacting your peers.

FEATURED CUSTOMERS