Drug GMP Warning Letter Issued Without Facility Inspection

Are there high-risk drugs on the market that do not require an FDA drug application submission, approval, or a facility inspection to be marketed? Yes. We know that FDA can issue warning letters based on website reviews – for example, for obviously false claims or claims not substantiated by data that has been submitted to […]

Unique IDs for Life Sciences Quality and Regulatory Data – Redica ID vs. FEI

One of the biggest challenges in the field of Quality and Regulatory Intelligence for Life Sciences is that the majority of the data that needs to be analyzed is unstructured, which prevents objective, apples-to-apples comparisons. It comes from many different sources with many different structures. Then, when it gets pooled for aggregated analysis, the previous […]

At GMP by the Sea, Redica Systems Corroborates FDA Example on the Spot

In August, Redica Systems had an unusual opportunity to show off the power of its Quality and Regulatory Intelligence at the 27th annual GMP by the Sea meeting in Cambridge, MD. After an FDA official presented the agency’s response to recent excipient contamination, Redica Systems corroborated — with charts — within hours, at the company’s […]

Looking Outside Your Four Walls at GMP by the Sea

It’s challenging enough to use Quality Management Maturity (QMM) within your own facility, and keeping tabs on suppliers is an even steeper climb. But the clues Redica Systems uncovers in regulatory data allow life sciences companies to complement existing QMM metrics for a much more predictive and proactive approach. “Most companies are using 50 percent […]

Welcoming Roger Angarita as Redica Systems’ New Chief Product Officer

Today, we’re thrilled to announce the latest addition to Redica Systems’ leadership team, Roger Angarita, who has joined us as the Chief Product Officer. Roger brings a wealth of experience and expertise in software and data product management and innovation, and we couldn’t be more excited to have him on board. Roger has an impressive […]

Expert Interview: The Role of Data Operations Inside Quality and Regulatory Intelligence

Data Operations is a fairly new discipline, but it has rapidly become critical to the success of nearly every type of company. In a September 2023 interview with Scott Sherrill, the Vice President of Data Operations at Redica Systems, we discussed the greatest challenges and opportunities for DataOps within the Quality and Regulatory Intelligence space, […]

Expert Interview: The CTO’s View of Quality and Regulatory Intelligence for Life Sciences

The Chief Technology Officer of a data analytics company is central to the products and solutions that company ultimately delivers. In a September 2023 interview with AJ Saha, the CTO at Redica Systems, we discussed the greatest challenges and opportunities for data structuring and processing, AI/ML, and much more within the Quality and Regulatory Intelligence […]

Expert Interview: How Redica Systems Serves Medtech

The rapidly evolving fields of data analytics, AI/ML, and managing compliance risk are of special importance to the MedTech / med device industry. In a September 2023 interview with Alison Sathe, the Senior Vice President of Medtech at Redica Systems, we discussed the greatest challenges and opportunities as well as what the future might hold. […]

FDA Post-Warning Letter Meetings are Not Agency Consultations

After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a meeting with FDA to discuss remediation efforts resulting from the deficiencies cited in the letter, as described in a recently released draft guidance. At the PDA-FDA Joint Regulatory Conference on September 20, 2023, in Washington, DC, FDA Center […]

What is “Quality and Regulatory Intelligence”?

Quality and Regulatory Intelligence (QRI) allows life sciences companies to reduce compliance risk and improve product quality with analysis of regulatory updates and the corresponding agency enforcement actions. In the life sciences industry, major players have employed Regulatory Intelligence for years, diligently tracking changes in the global regulatory landscape to maintain compliance and, increasingly, using […]
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