How we process data

We take a structured, scientific approach to processing data, ensuring accuracy and clarity. By systematically breaking down information, we minimize gaps and provide deeper industry insights for any query or use case.

Step 1

Step 2

Step 3

Step 4

Aggregate

Input Documents

We collect and prepare documents for processing.

Sources

We link our documents back to the sources

• FDA Data Dashboard
• FOIA Requests
• Independent Journals

Process

We fundamentally structure FDA Data, based on various measures, such as:

• Document type (483, WL, EIR, etc.)
• Document Source

In our data assembly phase, we structure keywords, analyze new concepts and parse our documents.

For any given registration number, we can compile data points beyond inspection records, integrating multiple data sources to create a more comprehensive company profile.

Review

GKS Assembles the Best Teams

• Our team includes former FDA experts, auditors, and journal reviewers.
• They ensure the accuracy and integrity of our critical data, methodologies, and QA/QC processes.

 GKS Conducts Comprehensive Data and Trend Reviews

• We leverage both internal teams and external advisors to systematically review data, focusing on trends, keywords, and regulatory codes.

Critical Updates

Our reviewed and structured data is delivered directly to you. We compile and display:

• Regulatory Summaries - Concise insights from FDA reports
• Visual Data – Graphs, bar charts, and trend analysis
• AI-Driven Insights – Keyword tracking and compliance updates

Our suite of novel AI capabilities includes advanced keyword matching and intelligent querying for precise data retrieval.

Real-World Applications

How Our Data Powers Smarter Decisions

Our advanced features go beyond basic data presentation, providing deeper insights, enabling smarter decision-making, and turning information into actionable results

Monitoring Compliance

"I want to track my API Suppliers in India, can you assist?"

Here's a list of all API companies in India. Would you like to save this as a clustered search for continuous updates?

• See the interactive map view.

• Explore the full company list.

• Track CFR codes, citations, and compliance violations over any date range.

Our Answer

Map View

Interactive Map View for Real-Time Monitoring

Champion Issues with your organization

"We want to train our staff about XYZ, but they don't see it as an issue. Can I pull a quick fact to demonstrate that the FDA cares?"

This issue has been cited in 5 FDA warning letters and 10 FDA Form 483 reports. Would you like to explore related violations and trends?

Our Answer

GKS Data Dash Board

Instant Access to FDA Compliance Data.

Landscape monitoring

"A client of ours received a citation for 21 CFR 211.192. Can I monitor other companies that recieved this violation in my industry?"

21 CFR 211.192 recently had 76 inspections, 63 related FDA Form 483s, and 12 associated warning letters. Scroll below to explore related keywords and impacted companies.

Our Answer

Code/company view pages

Track Regulatory Trends Across Companies and Industries.