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

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

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

January 28, 2026
Scott Sherrill
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Latest Blog Posts

Product Insights

Redica MCP Gateway: Context Engineering Tools

January 15, 2026
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
API
Digital IT Teams
Financial Services
Trends

FDA Increased For-Cause Inspections Almost 250% in 2025

November 12, 2025
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
483
Draft Guidance
FDA
Microbial Control
Non Sterile
Product Insights

Deep Dive Into Data Explorer: Your Analysis Interface

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

Deep Dive Into Spaces: Your New Command Center

October 8, 2025
AI
AI-Powered
Redica Systems
Smart Folders
Spaces
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Company news

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Company News

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

January 28, 2026
Company News

Redica Systems Announces $30M Series B

December 9, 2021

Conference Spotlight

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Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024
Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024
Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024

Enforcement

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Enforcement

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

January 28, 2025
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
Enforcement

Navigating FDA Guidelines for Combination Products: A Comprehensive Guide

November 6, 2024
Enforcement

ICH Q9 Quality Risk Management in Pharma

October 15, 2024

Inspection Intelligence

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Post-market Intelligence

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Post-Market Intelligence

FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting

December 1, 2025

Product News

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Regulatory Intelligence

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Site Intelligence

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Alison Sathe
Anders Vinther
Arijit Saha
Ayan Ghosh
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Sarah Kotler
Scott Sherrill
Yelena Ionova
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2011 process validation guidance
2022 PDA Annual Meeting
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483
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483 Response Letter
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Alison Sathe
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Cell and Gene
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Donald Ashley
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