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QUALITY SYSTEMS

We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.

QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.

Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.

QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.

Quality Systems

Quality By Design

We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.

QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.

Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.

QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.