Why choose Redica to stay on top of the ever-shifting global regulatory landscape?

Comprehensive Regulation and Standards’ monitoring to put the “c” in cGxP

In this demo you will dive into:

  • Global GxP source coverage
  • Enriched and searchable content 
  • Simple dashboard
  • Integrated workflows for triage and impact assessments
Chosen by global leaders and innovators

Comprehensive regulatory monitoring

One Dashboard to simplify your life

Pull up the only feed you will need to stay on top of the incredibly complex and ever-shifting global regulatory landscape. Change your risk profile by dramatically reducing the risk of being unaware.

Get your arms around the world

External Monitoring includes data sets such as:
Customized feed to stay focused

Go beyond keyword-based-search and tailor your experience using powerful Redica labels that include Industry, Scope (eg GLP, GMP, GCP, GMP for IMP etc), Source (eg EMA and US FDA).

Top trends and themes

Get the key topics that keep the Industry awake at night at your fingertips, with pre-triaged themes like Nitrosamines, Data Integrity, Cell & Gene Therapy, Cybersecurity, and much more.

End-to-End Regulation Lifecycle

Get Signals across the entire Regulation Lifecycle, from the early noise (eg agencies work plan, strategies, concept papers) all the way through Final Regulation and Enforcement.

“Big pharma” capability
at the push of a button

Discover how a recently approved for market therapeutic drug company leveraged Redica’s External Monitoring as a one-stop-shop to get ahead of the Business Development team and to stay prepared.

Challenge

With one drug in the market and a robust pipeline of candidates, the Business Development and Regulatory Affairs teams were hungry to grow revenues by submitting in more than six new markets, including the UK, Australia, Canada, China, and Japan.

The small quality team of 3 needed to ensure that it could understand and be in compliance with regulations from these new markets.

“We needed to get in front of the wave.”
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Solution

The team utilizes our External Monitoring module, a one stop shop regulatory surveillance solution for GLP, GCP, GMP for IMP, GDP, and GMP monitoring across Human Drugs, Biologics, Medical Devices, Animal Health & IVD.

Solution includes a simple dashboard that is tailored to individual needs so they only see pertinent and valuable information – no more sifting through the weeds and newsletters!
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Impact

In less than 5 minutes, the team was set up and accessing our comprehensive market coverage to help them understand regulatory requirements in new markets, new guidance and new regulations.

Team members now spend less than one hour per week to scan and triage all applicable regulatory change related to their product lines, and the time to impact was almost immediate.

“We get turn key big pharma tools and capabilities with minimal effort.”
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“This is truly remarkable. I have never seen analytics this granular for GCP.”

Clinical Quality Assurance, Johnson & Johnson

“We didn’t know what we didn’t know. Now, Redica helps us be more risk-based and to refine our agenda for audits.”

“Redica is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.”

Director of Quality, Amgen