Resources

Explore our library of free resources including assessments, reports, webinars,
and more designed to make your job easier.

ASSESSMENTS

FREE ASSESSMENT

Discover the power of the most comprehensive database of 483s in existence. Our database of over 21,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

FREE ASSESSMENT

Don’t be surprised. Know what’s happening at your sites. Get your free Site Profile and quickly see the 483 issuance rate, view all citations, get a complete list of inspectors, and more.

FREE ASSESSMENT

What was the most cited problem in your peer group? Find out! Get your free personalized report.

FREE ASSESSMENT

Get to know your inspector before they arrive. On your inspector shapshot you will see inspection history, issuance rates, citation trends.

FREE ASSESSMENT

How do you compare to your peers? See how the Govzilla platform can quickly and easily benchmark your performance relative to your competition. 

FREE ASSESSMENT

Shine a light on your CMOs. Get your free assessment of the top 5 sites you are interested in learning more about and discover their FDA inspection history, keyword analysis for critical items encountered, and more.

FREE ASSESSMENT

See how enforcement compares among generic drug manufacturers. Our database of over 21,000 483s is retyped and tagged, making it easy to benchmark companies in seconds.

INSPECTION DOCUMENTS, CHECKLISTS, WEBINARS

INSPECTION DOCUMENT

See for yourself what the items required in a 510k submission look like in action.

FREE CHECKLIST

Be prepared for your next drug review. Know the do’s and don’ts. Have this expert-approved checklist handy when it comes time to talk with the FDA.

FREE WEBINAR

Download the slide deck and video presentation of this informative webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.

REPORTS

FREE REPORT

In this report you will see Trends since FY2015, CFR citation frequency, observations associated with Donor Eligibility and Current Good Tissue Practice, and more.

FREE REPORT

Know the Data Integrity Issues
Download your COMPLETE copy of the report by Barbara W. Unger,
“Analysis of CY2018 FDA Warning Letters That Cite Data Integrity Failures.”

FREE REPORT

Know the risk factor now. Download your complete copy of the report by Barbara W. Unger.

FREE REPORT

Download this graphical report full of unique and valuable data created by the Govzilla platform. How does Asia Pacific compare to CDER averages by region? What two Asia Pacific countries receive the most warning letters? Find out!

FREE REPORT

Download this graphical report full of unique and valuable data created by the Govzilla platform. What types of firms are taking the heat? And where are they located? Find out!

FREE REPORT

An expert review of CDER’s State of Pharmaceutical Quality Report. Download your complete copy of the report by industry expert Barbara W. Unger.

FREE REPORT

Identify new FDA inspection trends to proactively address similar situations in your company.

FREE DOWNLOAD

Get the Inspector Profile of one of the FDA’s most renowned investigators. On Peter Baker’s Inspector Profile you will see inspection history, issuance rates, citation trends.

FREE REPORT

In this report you will see Trends since FY2015, CFR citation frequency, observations associated with Donor Eligibility and Current Good Tissue Practice, and more.