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Redica Systems

@RedicaSystems

Data analytics for quality and regulatory intelligence in #lifesciences. Built for quality professionals to reduce compliance risk.

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"You don't GET inspection ready, you have to BE inspection ready." Watch this excellent video overview from our Sales Manager, Sam McDonald, as he shows you how to prepare for an #FDA pre-approval inspection. [ 🔊 sound on!] redicasystems.wistia.com/medias/la1i2e1… #lifesciences #FDAapproval


As we wrap up 2024 and head into 2025, we make some specific recommendations for how FDA can make progress against some of its biggest challenges: hubs.la/Q02Yrgtd0


Join Alison Sathe, Hannah Rosenfeld, and Paul Hanson for two informative panels at the AFDO/RAPS Healthcare Products Collaborative 2024 AI Summit next week in Cincinnati: invt.io/1lxb2f3yla5

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Less than a week away! Join @StephanieG_PAI from @PharmatechA for an insightful discussion on the importance of proactive quality approaches and reducing the hidden costs of poor quality. Submit your questions in the registration form! hubs.la/Q02XsFDL0 #pharma

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New webinar on the calendar with @StephanieG_PAI from @pharmatecha! Join us for an insightful discussion on the importance of proactive quality approaches and reducing the hidden costs of poor quality. hubs.la/Q02WdlKR0


In just 8 days, catch @JerryChapmanGXP speaking @AAPSComms - "Developing a Risk Score for Critical Suppliers Using Artificial Intelligence (AI)" #PharmSci360 cdmcd.co/RxZdQX


At #pdafda 2024 in DC, FDA clarified exactly which entities in the pharma supply chain are responsible for CGMP compliance: hubs.la/Q02S-64Q0


[new post] What is the purpose of FDA VAI or OAI Regulatory Meetings, and how do they differ from one another and other regulatory meetings? hubs.la/Q02Sdjpn0


[NEW POST] Case Study: Brassica - Analysis of FDA enforcement actions leads to the correct prediction of a Warning Letter. hubs.la/Q02R7Hhw0 #fda #fda483 #qualityassurance


Excellent new @PDAonline post by @MgVantrieste, "The High Cost of Cheap Drugs": pda.org/pda-letter-por…


If you work in Quality or Regulatory for a #MedTech company, you know how tedious it is to find and compile FDA MAUDE data for Regulatory Records. Learn how to cut that time in half: hubs.la/Q02QvlwS0 #medicaldevice #qualityassurance

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Our SVP of Data Strategy and Analytics, Alison Sathe, is debuting the new #MedTech Postmarket Intelligence capability from Redica Systems on this September 25th webinar. Register here: hubs.la/Q02PS1M10 She is also attending #rapsconvergence in Long Beach, CA next week.

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Our team at @PDAonline #pdafda is enjoying DC!

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If you missed yesterday's webinar with former FDA Investigator and current CREO Director Vin Cafiso on Calculating the Cost of Quality for Life Sciences, you can catch the recording here: hubs.la/Q02P0Rbz0 #medtech #quality


A Warning Letter hasn't yet been issued to Cipla following this recent, worrisome 483, but we believe it likely will soon. Download the full report on this 483 here: hubs.la/Q02NV95x0

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🔎 When a FDA Investigator shows up at your site, what do they typically look for? What is top of mind for them? Hear first hand from FDA national expert pharmaceutical investigator Simone Pitts: hubs.la/Q02MY6w70


We're coming to Boston in Sept! Our CEO Michael de la Torre will be presenting on how life sciences companies can make better supply chain partner decisions using Vendor Risk Scoring: gxp-cloudcompliance.com/speaker/michae…

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