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The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by

FDA Regulations[...] Read More

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by

Data Integrity[...] Read More

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by

Medical Device Compliance[...] Read More

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance Practices[...] Read More

How Compliant Are Your Medical Devices with EU Cloud Computing Regulations?

February 4th, 2015 by

EU Medical Device Cloud Computing Regulations[...] Read More

Is It Time for Your Firm to Undergo an FDA Mock Audit?

January 19th, 2015 by

FDA Mock AuditAmong compliance tools, FDA mock audits are [...] Read More

What Role Will Supplier Audits Play in Your Supply Chain’s Integrity?

December 2nd, 2014 by

Supplier AuditsWhere’s the weakest link in [...] Read More

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 Response[...] Read More

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations [...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing Validation[...] Read More