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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
featured

Latest Blog Posts

Product Insights

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

October 1, 2025
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
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
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Trends

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

May 15, 2025
DEG
DEG-contaminated
DEG/EG
diethylene glycol
EG
Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
FDA
FDA Oversight
Patient Safety
Enforcement

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

January 28, 2025
FDA
import alert
Inspection
Tianjin Darentang Jingwanhong
Tianjin Darentang Jingwanhong Pharmaceutical
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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
101
2011 process validation guidance
2022 PDA Annual Meeting
2024 highlights
483
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483 Response Letter
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503B
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510k
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API Manufacturer
Alison Sathe
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Cell and Gene
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Combination Products
Comparison report
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ConOps
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DCT
DEG
DEG-contaminated
DEG/EG
DIGEMID
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Data Explorer
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Donald Ashley
Draft Guidance
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