Redica Systems
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Data analytics for quality and regulatory intelligence in #lifesciences. Built for quality professionals to reduce compliance risk.
During a March 2024 inspection of a finished drug company in China, FDA investigators Brandy Lepage and Karen Briggs encountered company management that limited access to manufacturing areas, disallowed photography, and supplied fewer documents than requested, many of them heavily redacted.
Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter | Redica Systems
Redica is a platform for life sciences companies to analyze data, improve product quality, and reduce regulatory risk. Read Limiting Plant Access and Sharing
redica.com
February 17, 2025 at 5:53 PM
During a March 2024 inspection of a finished drug company in China, FDA investigators Brandy Lepage and Karen Briggs encountered company management that limited access to manufacturing areas, disallowed photography, and supplied fewer documents than requested, many of them heavily redacted.
Keep up the good work!
🎉 EMA celebrates its 3️⃣0️⃣th anniversary highlighting its evolving role at the centre of the EU assessing & authorising safe, high-quality medicines for 450 million people & countless animals in Europe.
Learn more about EMA’s key achievements over the past 30 years: www.ema.europa.eu/en/news/ema-...
Learn more about EMA’s key achievements over the past 30 years: www.ema.europa.eu/en/news/ema-...
EMA celebrates 30 years of progress in science and medicines in the European Union | European Medicines Agency (EMA)
Agency marks milestone highlighting its changing role in Europe
www.ema.europa.eu
January 27, 2025 at 4:43 PM
Keep up the good work!
Have thoughts on a topic in life sciences quality and regulatory compliance? Get your name out there via the Redica Systems blog and/or webinars! While you're there, hit that blue subscribe button so you don't miss out on our 2x monthly newsletter: redica.com/blog/
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#pharmsky
January 16, 2025 at 6:24 PM
Have thoughts on a topic in life sciences quality and regulatory compliance? Get your name out there via the Redica Systems blog and/or webinars! While you're there, hit that blue subscribe button so you don't miss out on our 2x monthly newsletter: redica.com/blog/
#pharmsky
#pharmsky
This Mylan 483 from May 2024 was our most popular single document in December: redica.com/document-sto...
Mylan Laboratories Limited - Form 483, 2024-05-24 - Redica Systems Store
Mylan Laboratories Limited - Form 483, 2024-05-24 inspected on May, 2024 Inspected by FDA Investigator: Arsen Karapetyan and 1 others.
redica.com
January 8, 2025 at 5:12 PM
This Mylan 483 from May 2024 was our most popular single document in December: redica.com/document-sto...
Preventing drug shortages is one of the biggest challenges facing FDA. We've been working on using data to forecast shortage risk for any specific drug category. This new guest post from Katie Terry highlights exactly how: bit.ly/predicting-d...
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#pharmsky
Using CGMP Site Risk Scores to Predict Drug Shortages | Redica Systems
Redica is a platform for life sciences companies to analyze data, improve product quality, and reduce regulatory risk. Read Using CGMP Site Risk Scores to
bit.ly
November 26, 2024 at 9:49 PM
Preventing drug shortages is one of the biggest challenges facing FDA. We've been working on using data to forecast shortage risk for any specific drug category. This new guest post from Katie Terry highlights exactly how: bit.ly/predicting-d...
#pharmsky
#pharmsky
Using Redica Systems as an early warning system - Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings - will it result in a Warning Letter? bit.ly/4iiIALw
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#pharmsky
Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings | Redica Systems
Redica is a platform for life sciences companies to analyze data, improve product quality, and reduce regulatory risk. Read Granules India FDA 483 Includes
bit.ly
November 26, 2024 at 9:44 PM
Using Redica Systems as an early warning system - Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings - will it result in a Warning Letter? bit.ly/4iiIALw
#pharmsky
#pharmsky
As we wrap up 2024 and head into 2025, our VP of Data Ops offers some specific recommendations for how @fda.gov can make progress against some of its biggest challenges: redica.com/addressing-f...
#pharmsky
#pharmsky
Addressing FDA’s Biggest Challenges | Redica Systems
Redica is a platform for life sciences companies to analyze data, improve product quality, and reduce regulatory risk. Read Addressing FDA’s Biggest
redica.com
November 21, 2024 at 5:12 PM
As we wrap up 2024 and head into 2025, our VP of Data Ops offers some specific recommendations for how @fda.gov can make progress against some of its biggest challenges: redica.com/addressing-f...
#pharmsky
#pharmsky
🌶️ This one is spicy: An "FDA inspection of API manufacturer Global Calcium Pvt. Limited, in Hosur, Tamil Nadu, India, revealed that blatant data falsification and manipulation continue to take place at factories that supply drugs to the U.S. market." redica.com/fda-inspecti...
#pharmsky
#pharmsky
November 21, 2024 at 5:07 PM
🌶️ This one is spicy: An "FDA inspection of API manufacturer Global Calcium Pvt. Limited, in Hosur, Tamil Nadu, India, revealed that blatant data falsification and manipulation continue to take place at factories that supply drugs to the U.S. market." redica.com/fda-inspecti...
#pharmsky
#pharmsky
We're on @bsky.app! Who should we follow in #lifesciences #qualityassurance and #regulatorycompliance?
mary poppins is flying through the air holding a kite with the words " prepare for my arrival " below her
ALT: mary poppins is flying through the air holding a kite with the words " prepare for my arrival " below her
media.tenor.com
November 19, 2024 at 5:12 PM
We're on @bsky.app! Who should we follow in #lifesciences #qualityassurance and #regulatorycompliance?