GKS Featured in PDA - Parenteral Drug Association - Regulatory Data Insights and Methods of Extraction and Analysis

GKS Authors Featured in PDA Journal of Pharmaceutical Science and Technology

Article Regulatory Data Insights and Methods of Extraction & Analysis

Global Key Solutions (GKS) is proud to have our work showcased in leading peer-reviewed and industry platforms. Our research and methodologies for regulatory data extraction and analysis continue to set the standard for inspection readiness and compliance intelligence.

Peer-Reviewed Publication:
Springer – Journal of Pharmaceutical Innovation

PDA Journal Feature:
PDA Journal of Pharmaceutical Science and Technology (Vol 79 Feature 4) – Regulatory Data Insights and Methods of Extraction and Analysis

Event Spotlight:
Featured at PDA Week 2025, Palm Springs

Abstract

• This study investigates trends in FDA warning letter issuance between 2019 and 2023, focusing on the agency's efficiency and evolving priorities during this period. By analyzing both quantitative and qualitative data, the research highlights an increase of 43% in warning letters issued per 100 inspections. Using a novel approach combining regex filtering and web scraping, this presentation examines recurring keywords, department-specific citations, and legal references. The analysis aims to help attendees understand how structured data from regulatory agencies can be harnessed to improve compliance and inspection readiness.

Key Highlights

• From 2019 to 2023, the FDA went from issuing a warning letter 2.98 times per 100 inspections to 4.27 times per 100 inspections, a 43% increase in warning letters issued per 100 inspections.
• The FDA issued more warning letters more frequently when compared to inspection volume, reallocating resources and priorities throughout the COVID-19 pandemic.

Why It Matters

Going beyond retrospective data, document-based data now provides additional context for a variety of decisions within the life sciences industry.

• As context windows for LLMs and AI-based infrastructure expand, and as computing methods advance beyond strictly structured data, datasets like these can now integrate seamlessly with broader internal data assets, resulting in enhanced “quality” insights across workflows and improved decision-making. In short: stay informed, stay connected, and add context.

Author: George Kwiecinski
LinkedIn: linkedin.com/in/georgekwiecinski