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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.

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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Company News

Redica Expands Global Inspection Coverage with New PMDA, Swissmedic, EMA, and MFDS Data

January 28, 2026
Scott Sherrill
data
EMA
Global Inspection Coverage
Inspection Events
Korea MFDS
Product Insights

Redica MCP Gateway: Context Engineering Tools

January 15, 2026
Ayan Ghosh
Context Engineering
Data Sources
MCP Gateway
Redica AI
Post-Market Intelligence

FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting

December 1, 2025
Jerry Chapman
API
Digital IT Teams
Financial Services
Trends

FDA Increased For-Cause Inspections Almost 250% in 2025

November 12, 2025
No items found.
483
FDA
FDA inspection
For-cause
For-Cause Inspections
Trends

Non-Sterile Doesn’t Mean Low Risk: FDA Emphasizes Gaps in Microbial Control

October 27, 2025
Redica Systems
483
Draft Guidance
FDA
Microbial Control
Non Sterile
Product Insights

Deep Dive Into Data Explorer: Your Analysis Interface

October 24, 2025
Roger Angarita
Data Explorer
inspection readiness
Redica App
Redica Systems
Regulatory Intelligence
Product Insights

Deep Dive Into Spaces: Your New Command Center

October 8, 2025
Roger Angarita
AI
AI-Powered
Redica Systems
Smart Folders
Spaces
Product Insights

Introducing the New Redica: Integrated Intelligence for Regulatory and Quality Teams

October 1, 2025
Roger Angarita
AI-Powered
DaaS
data
Data Explorer
New App
Product Insights

Redica Data-as-a-Service (DaaS): Seamless Data Integration, Where You Work

September 11, 2025
Redica Systems
DaaS
data integration
data sharing
Data-as-a-service
snowflake

Redica Systems Closes Financing to Advance Predictive Quality and Regulatory Intelligence in Life Sciences

May 15, 2025
Redica Systems
No items found.
Trends

FDA Flags Repeat Offender for DEG/EG Testing Failures—Is Your Supply Chain at Risk?

May 15, 2025
No items found.
DEG
DEG-contaminated
DEG/EG
diethylene glycol
EG
Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
Jerry Chapman
FDA
FDA Oversight
Patient Safety
Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

January 28, 2025
Jerry Chapman
FDA
import alert
Inspection
Tianjin Darentang Jingwanhong
Tianjin Darentang Jingwanhong Pharmaceutical

Strategies to Improve Your CAPA Program: Addressing Key Compliance Risks

January 24, 2025
Jackie Torfin
CAPA
CAPA System

What Is a 510(k) Submission? A Complete 2025 Guide

January 14, 2025
Redica Systems
510k
510k submission

503B Outsourcing Facilities: A Complete 2025 Inspection-Readiness Guide

January 8, 2025
Redica Systems
503A
503B
503B outsourcing

Redica Systems Successfully Completes SOC 2® Audit

December 17, 2024
Redica Systems
No items found.

Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

December 9, 2024
Jerry Chapman
API
Case Study
CDER
FDA

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