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Quality, Regulatory & Compliance

In pharmaceutical manufacturing, your product affects people’s lives. It is essential to create and maintain a culture of quality—not just at launch, but at every stage of growth and development.

An overarching quality management system creates an infrastructure, embedding quality throughout every aspect of drug manufacturing. Developed in tandem with the manufacturing processes, it includes detailed procedures, explicit training, and above all, an inherent expectation of quality. 

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We keep the end in mind from the beginning

Carefully crafted policies and standard operating procedures (SOPs) serve two purposes: to satisfy regulatory authorities, and ultimately to ensure the safety of your product. From documentation hierarchy to change controls, training to NC/CAPA programs, we can develop your quality management strategy, then ensure it is correctly implemented.

  • Fit-for-purpose quality and compliance systems

    The path to market is full of inspections, from the health authority to regulatory authorities. With the right quality systems in place, you never have to worry. Precision accountability often extends to the pre-approval inspection; we always stand ready to defend the work we implement.

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    Quality Program Support

    • Supplier quality management program implementation
    • CMO and CDMO selection and management, quality agreements, person in plant
    • Quality risk assessments
    • NC and CAPA program development
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    Quality Management Systems

    • Policies and procedures (SOPs) development
    • Quality management systems implementation (EMS, LMS, EAM, CMMS)
    • eQMS vendor evaluation and selection
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    Data Integrity Part-11 Compliance

    • Quality gap assessments
    • Quality risk assessments
    • Remediation planning and execution
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    Regulatory & Compliance

    • Regulatory strategy and submissions
    • Audit preparation and support
    • Compliance remediation
    • Health authority inspection readiness
    • 483s

We know quality from the ground up

Our expertise in quality is grounded in practice. In countries around the world, we have led, launched, managed, and maintained the most complex drug manufacturing facilities. We know where potential issues lie—and how to effectively avoid them.

Tech ops capital investments managed
Facility builds and expansions led
Capital projects delivered
Cities globally with projects under management

People first and patient-focused

Our greatest resource is our people, with patients at the core of everything we do. Commitment to that value provides a foundation of success for us and our partners.