Specialized regulatory, quality, and program delivery expertise for medical device, pharmaceutical, and biotechnology companies.
Specialized support for CAPA programs and FDA Consent Decree or Warning Letter remediation.
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Strategic, credible response support when you've received an FDA Form 483 or Warning Letter.
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Establish and maintain robust supplier quality programs that meet ISO 13485 requirements.
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QMSR & ISO 13485 design control expertise spanning the full development lifecycle.
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ISO 14971 risk management programs built into your product lifecycle, not bolted on.
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Compliant complaint handling and post-market surveillance systems aligned to FDA, ISO 13485, and EU MDR.
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Process, equipment, and computer system validation aligned to FDA 21 CFR Part 820, ISO 13485, and GAMP 5.
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Quality and regulatory due diligence and integration support across the M&A lifecycle.
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Gap assessments, technical documentation, and transition support for the EU Medical Device Regulation.
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Experienced project leadership, staff augmentation, and IT delivery support for medical device companies.
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