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  • Nielsen and England: FDA s 1980s Approach to 21st Century Import Risk
    and devices that are safe and effective with something like an automated pre-shipment screening process or third-party inspection regime and then audit that process off line (after entry), it could use its precious HumINT and inspection resources on demonstrably higher-risk shipments or true unknowns
  • Medical Device Link .
    such as good manufacturing practices (GMPs), allowing third-party certification instead of requiring direct MHLW approval, and developing a market authorization holder (MAH) system. Today, application forms and certification processes for IVD products differ slightly from other medical devices
  • Whistleblower in Wyeth Case Speaks Out
    . In the complex world of biological vaccine manufacturing, anything that has a direct impact on SISQP must come under documented and/or validated quality control protocols and procedures. These quality requirements are audited by the company and at times by third-party consultants, as well as by CBER, the FDA 's
  • Medical Device Link . Industry News
    contamination, contrast media residuals, and packaging defects were observed among reprocessed catheters taken from German hospitals, reported Schr oer. As for 10 single-use biopsy forceps reprocessed by third-party companies
  • A CRADA Diary: Part I
    gaps in its understanding of the issues, but they appear to have realized that, as a third party, we had a different perspective than an operating pharma company. We offered some middle ground. We re trying to raise issues that are important to helping the industry understand the underpinnings

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