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Donatelle

BioQuality Inc.

BioQuality is a provider of quality, regulatory and compliance services. Offerings include independent verification & validation (V&V), testing and QA reviewer or auditor, design control/validation process, documentation to meet regulatory submissions, clinical submission activities,FDA inspection readiness and response, quality audits (internal and supplier), risk management approaches and strategies, cGMP, QSR - 21 CFR Part 820 and ISO 9001/13485/14971, and Six Sigma approaches for QSR implementations.

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