Generate critical medical device insights with our actionable data intelligence.
We’ll help you search, analyze, and derive valuable insight from thousands of FDA, MDSAP, and Health Canada data points covering medical devices and combination products, contract manufacturers, products, inspections, and enforcement.
Tailor insights to your specific compliance and risk concerns
Contact Us
Let us help you figure out the right plan for you or get started with a trial of our standard plan.
Download the Special Report
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
Compare two companies of your choice.
Enter your email address and someone will contact you shortly to customize your report.
Evaluate Your CDMOs
Enter your email address and someone will contact you shortly to customize your report.
Compare the inspection history of your CDMO sites.
Enter your email address and someone will contact you shortly to customize your report.
Compare the enforcement history of your CDMOs.
Enter your email address and someone will contact you shortly to customize your report.
Monitor compliance at your Clinical Investigator sites.
Enter your email address and someone will contact you shortly to get you started.
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.
Prepare for your next inspection.
Enter your email address and someone will contact you shortly to explore enforcement trends.
Prepare for your next inspection.
Enter your email address and someone will contact you shortly to explore observations and trends.
Prepare for your next inspection.
Enter your email address and someone will contact you shortly to run your custom report.
Get help choosing the right CRO.
Enter your email address and someone will contact you shortly to customize your insights.
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
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
In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
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.
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
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
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
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.
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
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
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
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
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
Unlimited Access to Reports and Data
Enter your email address and someone will contact you shortly.
Download the Special 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
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
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
Sign up for your FREE account today and get instant access to Enforcement Analytics.
Experience the Power of Redica Systems
Let us know who you are and we’ll be in touch to answer all of your questions and get you started.
Keep up with the latest Regulatory Developments on Clinical Trials
Enter your email address and someone will contact you shortly.
Save your team valuable time when using External Monitoring.
Enter your email address and someone will contact you shortly.
Save time and Resources when using External Monitoring.
Enter your email address and someone will contact you shortly.
Get immediate access to the news that matters to your sites.
Enter your email address and someone will contact you shortly.
See how we can help you eliminate yet another spreadsheet.
Enter your email address and someone will contact you shortly.
Stay ahead of changing regulations.
Enter your email address and someone will contact you shortly to get the data and analysis you need.
Upgrade your CDMO monitoring strategy.
Enter your email address and someone will contact you shortly to get the data and analysis you need.
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.