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Regulatory Surveillance with Redica Systems

In the video below, Sam will show you how easy we make staying up to date with the latest regulatory updates impacting your specific areas of interest (ex. GMP, GLP, GCP, Human Drugs, etc.).

Content Category and Themes

Customize your feed for what you need. Along with our sources, we have content categories and themes you can follow or remove from your feed. Get the key topics that keep the industry awake at night at your fingertips, with pre-triaged themes like Nitrosamines, Data Integrity, Cell and Gene Therapy, Cybersecurity, and much more. Go beyond keyword-based search and tailor your experience using powerful labels that include Industry, Scope (e.g., GLP, GMP, GCP, GMP for IMP, etc.), and Source (e.g., EMA and U.S. FDA).

Our content categories:

  • Authoritative Source, Other Publication
  • Inspections & Enforcement
  • News & Announcements
  • Reports & Papers
  • Rules, Regs & Guidance
  • Standards & Norms

More than just FDA Data

We monitor over 200 Global Regulators, Harmonizing Organizations, Standards Bodies, and Trade Associations, so you don’t have to! With Redica Systems, you can filter your feed for the scope that matters to you. Allowing you and your team to focus on the part of the business that matters to you. 

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“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.”

Regulatory Surveillance

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.”

EM