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Quality & Regulatory

Our team enables quality and regulatory excellence by combining our practical industry experience with a customized set of services.

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Consumer Products

Life Sciences

Quality & Regulatory Services

LIFE SCIENCES

Quality & Regulatory Experts

Janel Firestein

Partner, Life Sciences Industry Leader
Janel is a recognized expert delivering business results in the areas of regulatory compliance, business process improvement, change management, product development, quality systems, and strategy.

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Mike Leary

Partner
Mike has led global initiatives for companies that have included quality systems and ERP implementations, organizational design, and regulatory remediation and compliance initiatives.

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Nicole Taylor

Quality and Regulatory Service Lead
Nicole lends experience in operational and implementation services and is skilled in the application of GxP regulatory expectations and best practices to efficiently meet regulatory compliance requirements.

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Irene Birbeck Lewis

Associate Partner
Irene specializes in the management of quality systems process and technology implementations within the life sciences, with specific experience in the chemical, pharmaceutical, and biotechnology industries.

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Gary Richey

Pharma, Biotech, and Contract Manufacturing Industry Lead
Gary lends his expertise to leading life sciences clients in the areas of quality systems, business process improvement, change management, technology governance, and IT effectiveness.

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