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:

More than 200 customers
19 of the top 20 pharma
companies
9 of the top 10
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

Alberto Ochoa
Software Engineer
Alejandro Duarte Sánchez
Lead Developer
Alex Kouznetsov
Director Data Engineering and Data Science
Alfredo Siprian
Senior Frontend Developer
Amy Filbin
Barbara W. Unger
Senior GMP Expert
Barry Price
Research Analyst
Brandi Salomone
Customer Success Manager
Chelsey Langan
Chief Revenue Officer
Chris Martinez
HRBP, Talent Acquisition
Darryl Wanuck
Account Executive
Erika Martinez
Customer Success Manager
Estela Gil
Program / Operations Manager
Fred Leung
Product Manager
George Donev
Software Engineer
George Varagas
Director of Engineering
Japneet Kaur
Project Manager
Jarred Hudson
Data Scientist
Jason Kerr
Senior GXP Specialist
Jane Wastl
Senior GMP Expert
Jay Birk
CFO/COO
Jerry Chapman
Senior GMP Expert
Jessica Strmiska
Revenue Operations Manager
Jim Hoadley
Senior DevOps Engineer
Joanna Quach
Data Engineer
Jonathan Rochez
CTO
Joyu Lin
Account Executive
Junko Nagata
Senior QA Engineer
Justin Calareso
Data Engineer
Karen Gu
Product Manager
Karen Saldaña
Quality Assurance Engineer
Kelly Burrell
Customer Success Manager
Ken Skinner
Account Manager
Kevin King
Senior Software Engineer
Kris Christian
Service Operations Representative
Kristen Halstead
Account Manager
Lilia Tirado
Software Engineer
Lisa Vontalge
Service Operations Representative
Luis Mercado
Software Engineer
Mark Agostino
Senior GMP Expert
Marco Rocha
Lead Product Designer
Matthew Stephenson
Fullstack Engineer
Merwane Hamadi
Senior Software Engineer
Michael de la Torre
CEO
Michelle Call
Chief Strategy Officer
Mimi Swiatkowski
Account Manager
Patrick Waldo
Director of Product Management
Patty Harvey
Senior GMP Expert
Rebecca Stauffer
Content Strategy Manager
Roberto Ramos
Lead Frontend Developer
Robin Tubbs
Account Executive
Ryan Donohue
Head of Sales
Sam McDonald
Account Executive
Shafia Askari
Data Enginner
Shawn Vroom
Account Executive
Taylor Minks
Marketing Lead
Ty Phillippay
Account Manager
Vishnu Anand
Senior Data Engineer

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.
Image

In the News

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

The COVID Vaccines Are Approaching. Is the FDA Ready to Inspect the Plants Where They’re Made?

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

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

BLOOMBERG QUINT
Trouble Mounts For Biocon’s Bengaluru Plant
READ

BOTTLE OF LIES
The Inside Story of the Generic Drug Boom
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

Press Releases

Redica Systems

Govzilla Announces New Customer Platform and Company Name Change to Redica Systems
READ

FOIGovzilla

Govzilla and FOI Services Announce Strategic Partnership

READ

Govzilla-Valisure

Govzilla and Valisure Announce A Collaboration Focused on Creating A Platform For Evidence-Based Quality Scores For Drug Products

READ

Media Contact

Members of the media can contact [email protected] with any inquiries.

Download the Special Report

Quality Week report sidebar

What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

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
Redica Systems Enforcement Analytics

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.

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Panel Discussion – Remote Audits

Panel Discussion opt in image

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.

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
Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS 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

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies 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

Redica_Vert_Periwinkle_RGB_Large

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.

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.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
  •  

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

Download the Special Report

Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

Experience the Power of Redica Systems

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

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.

Download the 510(k) Sample

What You Will Learn from This Sample:

See how a 510(k) submission is structured

Find out what information to include

Review correspondence between sponsor and FDA

Redica Systems Enforcement Analytics

Unlimited Access to Reports and Data

Enter your email address and someone will contact you shortly.

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

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

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

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.