In pre-clinical and clinical programs, our subject matter experts analyze risks, examine business models and fiscal planning, review basis of design, monitor administrative + engineering controls, and provide regulatory compliance support—the combined efforts of which lead to improved patient safety.


Engineering Controls

  • Analyze business model

  • Provide risk analysis

  • Develop and coordinate strategic plan

  • Develop program of requirements

  • Create Basis of Design

  • Provide Fast Fail pharmaceutical study

  • Provide continuous quality control (CQC)

  • Provide IQ / OQ

  • Train O+M staff

  • Provide O+M teams

Operations Support

  • Develop regulatory plan and submission

  • Confirm CGMP / GLP / GTP parameters

  • Provide oversight during design, construction and operations

  • Confirm ability to meet USP 797, 800, 823

  • Provide compliance auditing and pre-inspection

  • Develop pre-clinical plans, programs, and procedures including construction and operational phases

  • Develop and initiate clinical validation plans, programs, and procedures

  • Confirm ability to meet regulatory platforms necessary to operate

  • Support preparation for AAALAC accreditation

Compliance Support

  • Provide vivarium management

  • Provide vivarium operations

  • Provide IACUC management or membership

  • Provide veterinary support

  • Conduct staff training

  • Identify equipment, conduct procurement, and oversee installation


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