Our Expertise

Computer System Validation

Our CSV approach guarantees faster project delivery and better system quality by adopting the FDA's CSA approach to reduce documentation burden and test scripts while ensuring alignment with regulatory practices.

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Data Integrity

Learn more about our team's expertise in providing a holistic validation package to demonstrate the data integrity and compliance of your company’s computerized system.

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IT Project Management

Our expert consultants will analyze and model business processes, and manage IT solution implementation keeping the team focused on delivery and mitigating schedule and budget risks.

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Commissioning, Qualification & Validation

Our team supports our clients throughout the full CQV life cycle by providing a comprehensive approach to facilitate a timely and cost-effective solution.

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Engineering Project Management

Learn more about how our consultants adopt a full life cycle management method involving a stage-gate approach to reduce risk exposure and increase the project success rate.

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Quality, Compliance & Operational Excellence

Learn how our experience and thorough understanding of the current GMPs, industry best practices, and operational improvements can benefit you.

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Regulatory Affairs

Learn more about how we can effortlessly guide you through any regulatory need, inspection, or application readiness.

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Training

Our expertise in CQV, CSV, PMP, and Agile along with our interactive LMS gives us the ability to provide you with training content that will help increase your company’s and employees’ potential.

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