Our Services

Is it broken? We can fix it. Do you need it approved? We can help you get it there. Is there are problem? We can investigate and offer scientifically-based solutions. Just need a little extra help? We can provide quality oversight and additional QA/QC staff. Is the FDA at your front door? Call us now and we’ll be there.

Practical Quality Solutions.

Quality Audits

We perform value-added internal and external quality audits for our clients around the world. We also manage global vendor audit programs and provide vendor quality metrics.

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PAI Readiness

The FDA Pre-Approval Inspection (PAI) is one of the most important events for a company. We perform gap assessments, inspection training, facility walkthroughs, and on-site support.

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Quality System Implementation

We specialize in developing compliant Quality Systems that meet the needs of the business. We work with both individual facilities and corporate quality programs.

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FDA Remediation

FDA 483s, Warning Letters, and Consent Decrees. We take clients through the investigation and remediation process while educating them on the necessary documentation for US FDA.

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Clinical Quality

We work with clients to provide Clinical Quality Programs that meet US and international requirements. We also perform clinical quality audits and BIMO mock inspections.

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Technical Services

QA/QC professionals are available to assist with daily operations, Annual Product Review, Management Review, data review, training programs, document control, batch record review and more!

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Supply Chain Capability

We provide supply chain services including warehouse audits, vendor qualification programs, US FDA Import Alerts, product recalls, trade agreements & SOP development.

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Software Implementation & eQMS

Software & electronic Quality Management Systems (eQMS) that meets your business needs. We work with industry leading software companies to implement best in class software.

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