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Quality Assurance & Compliance
We help our clients achieve and maintain compliance with applicable regulatory requirements, including FDA Good Manufacturing Practice (GMP) regulations, Quality Systems Regulation (QSR), Good Laboratory Practice (GLP) regulations, Good Clinical Practice (GCP) rules and guidelines (FDA/ICH), and ISO 9000 and other ISO standards. Our services include:
- Audits for regulatory compliance
- GMP, QSR and GLP audits and training
- Clinical study (bioresearch monitoring) audits
- Comprehensive support for compliance with FDA chemistry, manufacturing, and control requirements
- Technical and regulatory support in response to allegations of violations, and for clients operating under Consent Decrees
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