Redica Systems Announces Addition of Larry Coble as Chief Revenue Officer

PLEASANTON, CA, June 1, 2022 — Redica Systems has announced a critical addition to its executive

Redica Systems Appoints New CTO to Accelerate Technological Innovation in the Next Stage of Growth

PLEASANTON, CA, May 3, 2022 —  Redica Systems, a global leader in data and software for regulatory

Redica Systems Announces $30M Series B

Redica Systems Announces $30M Series B Led by Savant Growth to Bring New Analytics and Compliance Platform

Subscribe to our Blog

Discover The New Enforcement Analytics

Webinar – General Announcement Campaign – C

Govzilla’s Top 20 Posts of All Time

Over the years, the Redica blog (formerly Govzilla) has published over 725 articles covering a breadth of

March 483s: Most Popular and Newsworthy

In March, FDA posted five Form 483s to pharma firms and eleven to compounding/outsourcing

Warning Letters Week of 3/15/2020: Data Governance Failures

FDA is halting domestic pharma inspections based on a recent article from RAPS. Shortly after the RAPS

Drug GMP Warning Letter Issued Without Facility Inspection

Are there high-risk drugs on the market that do not require an FDA drug application submission, approval,

Looking Outside Your Four Walls at GMP by the Sea

It’s challenging enough to use Quality Management Maturity (QMM) within your own facility, and keeping

FDA Post-Warning Letter Meetings are Not Agency Consultations

After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

In Part 1 of this article, we explored FDA’s policy on reviewing internal audit reports as outlined in

Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

FDA Site Selection Model Updated to Include Regional Risk Factors A late-June 2023 update to FDA’s

How Redica Systems Goes Further than the FDA Data Dashboard

Note: The data provided in this post was gathered in July 2023.   Compared to other global

Redica Responds: What are Common Laboratory Inspection Findings?

Redica Responds is an article series where we take common/unique questions from customers and industry

Is Raw FDA Data Skewing Your Analyses?

Which GMP quality system was most often linked to FDA drug recalls since 2012?  Redica’s Jerry

Webinar – Vendor Management through Conforming Contracts

Webinar – Quality Intelligence Q&A with Peter Baker & Ulrich Köllisch

Webinar – Insights from Mapping API Inspection Deficiencies to the Quality Systems

Report – First FDA Warning Letter to Excipient Manufacturer Provides Lessons

Report – Intas Pharmaceuticals’ Troubles with FDA Continue

Report – Expert Analysis: 22 years of FDA Drug GMP 483s

Assessment – Investigator Snapshot

Assessment – Site Snapshot

Avoiding the Trap of a Data Swamp

“Data is the new oil” is a phrase attributed to British mathematician Clive Humby in 2006. While data

Drug GMP Warning Letter Issued Without Facility Inspection

Are there high-risk drugs on the market that do not require an FDA drug application submission, approval,

Unique IDs for Life Sciences Quality and Regulatory Data – Redica ID vs. FEI

One of the biggest challenges in the field of Quality and Regulatory Intelligence for Life Sciences is that

Product Sheet – Enforcement Analytics

Product Sheet – Machine Intelligence

Product Sheet – External Monitoring

ABC News | Aug. 1, 2022

This report uses Redica Systems data on FDA inspection findings to identify trends in Cronobacter

New York Times | Sept. 19, 2021

In this op/ed column, the author describes findings from a pharmaceutical plant inspection using

ABC News | April 20, 2021

Emergent’s spotty track record: What years of inspection reports show about firm tasked with helping make