Redica Systems created the first of its kind quality and regulatory intelligence (QRI) platform for the life sciences and food industries. We index and augment vast quantities of data and then partner with quality and compliance teams, helping them use that data to stay compliant and improve product quality.
Our vision is to simplify and guide quality and compliance decision-making with data.
Our customers operate in highly regulated industries:
companies
medical device
companies
About our new name
Redica Systems is our new formal name, a symbol of the next chapter in our company’s story.
As we considered the ways that our Quality and Regulatory Intelligence (QRI) platform is evolving to serve our customers, we sought a strong, sophisticated identity to match.
The promise we make to help customers derive actionable intelligence and valuable insight is firmly rooted in our data. Embedded in an essential system that includes our dual expertise in life sciences and trends analysis, our data give us the tools to empower the champions of quality and safety—to simplify compliance, to boost business growth, or simply to provide peace of mind.
“Redica” is a derivative of the Latin words, redicor and radicor, meaning to grow roots or take root. In combination with our new logo, the name signals an interconnected and supportive system built to foster new growth—and value—for our customers.
Our Story
2010
– FDAzilla founded
2010-2016
– Store offering 483s and FDA inspector profiles
– 2 engineers
2017
– Name changed to Govzilla, reflecting our expansion beyond the FDA
2017-2020
– New ownership structure and leadership team
– Addition of two subscription-based modules (enforcement analytics and external monitoring)
– 5 engineers
2020
– External capital raise
– 3 platform modules with a global scope, focused on quality and regulatory intelligence automation
– 30 engineers
November 2020
– Name changed to Redica Systems
We always bring the best of our company to help our customers meet and exceed their goals
With headquarters in Pleasanton, CA, our team is based all across the United States. We are relentlessly focused on our customers and strive to bring them the data, insights, and expertise that make their lives easier.
Our Team
We continue to grow
our team
Working at Redica Systems
- We believe strongly that we each have a responsibility to build our company and make our customers successful.
- We take pride in maintaining a positive and supportive culture, which starts by taking care of ourselves and our own development.
- With a dispersed team working from locations spread around the United States, we value open communication, transparency, and the freedom to speak up—no matter one’s role, experience, or tenure.
- We are relentless in our focus on our customers and we know they value our partnership with them.
- We are always looking for curious, independent, and hard-working team players interested in joining our team and making lives easier for the champions of quality and safety.
Current Openings
In the News
VANITY FAIR
The COVID Vaccines Are Approaching. Is the FDA Ready to Inspect the Plants Where They’re Made?
READ
THE NEW YORKER
The Birth-Tissue Profiteers
READ
BLOOMBERG BUSINESSWEEK
Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
READ
REGULATORY FOCUS
Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues
READ
MEDSCAPE
‘Scary World’ of Generic Drug Manufacturing, Revealed
READ
THE WALL STREET JOURNAL
Open-Government Laws Fuel Hedge-Fund Profits
Hedge Funds Are Using FOIA Requests to Obtain Nonpublic Information From Federal Agencies
READ
BOTTLE OF LIES
The Inside Story of the Generic Drug Boom
READ
BLOOMBERG QUINT
Trouble Mounts For Biocon’s Bengaluru Plant
READ
Press Releases
Media Contact
Members of the media can contact [email protected] with any inquiries.
Human Factors – Compliance and Applications
Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and Human Factors, Kaleidoscope Innovation
June 29, 1:30 p.m. EST
What you will learn:
- Human factors strategies from simple drug products to complex surgical devices
- Primary and secondary labeling development and evaluation for usability
- Human factors activities from product development to post-market
- International strategies: expectations for human factors in regulatory submissions in international markets
Panel Discussion – Remote Audits
Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates
Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.
Prepare for your next inspection.
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Prepare for your next inspection.
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Get help choosing the right CRO.
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Compare two companies of your choice.
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Download the Special Report
In this summary we identify:
- Trend analysis of FDA inspections through mid-2020
- Strategies for preparing and hosting virtual inspections
- New technologies to support remote inspections
Download the Special Report
In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
Turning Failure into Success
Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble
What you will learn:
- How to use the Leadership SOS Model to transform quality culture
- How to strengthen quality systems to eliminate human error
- How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Prepare for inspections of Clinical Investigator sites.
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Get Full Access to Redica Enforcement Analytics
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Quality Management Systems for Small Pharma and Biotech Firms
Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate
Get instant access to the webinar video and slides.
What you will learn:
- —Common challenges small pharma firms face when developing a QMS
—Recent enforcement trends involving the Quality Unit
—Impact of the COVID-19 pandemic
Download the Special Report
In this summary we identify:
GMP data from FY2017 to FY2020 for the Asia-Pacific region
Top 3 GMP primary and secondary citations
Download the Special Report
In this summary we identify:
- Data from 2019 UK MHRA Inspections
- Trends from 2015, 2016, 2018, and 2019 inspections
- Conclusions drawn from an analysis of drug inspection data
Experience the Power of Redica Systems
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SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.
WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject
SITES Quickly assess inspection records including dates and inspectors across all of your sites
INSPECTIONS Complete list of FDA inspections by date, company, category, and country
Get Complete Access to the Redica Systems Platform
Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.
Prepare for your next inspection.
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Monitor compliance at your Clinical Investigator sites.
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Experience the Power of Redica Systems
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Upgrade your CDMO monitoring strategy.
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Keep up with the latest Regulatory Developments on Clinical Trials
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Save your team valuable time when using External Monitoring.
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Save time and Resources when using External Monitoring.
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Get immediate access to the news that matters to your sites.
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See how we can help you eliminate yet another spreadsheet.
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Stay ahead of changing regulations.
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Upgrade your CDMO management strategy.
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Compare the enforcement history of your CDMOs.
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Experience the Power of Redica Systems
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Upgrade your inspection strategy.
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Upgrade your inspection strategy.
Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.
Experience the Power of Redica Systems
Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.
INDEX INFORMATION Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.
STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.
ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.
Evaluate Your CDMOs
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Compare the inspection history of your CDMO sites.
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Discover the power of the most comprehensive database of 483s in existence.
Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.
Eliminate days of work and get your FREE personalized 483 Observation Report.