Contact Info

1230 Peachtree St. NE, 300 Promenade, Atlanta, GA 30309

Phone: +1 678-990-8001

Fax: +1 678-990-5399

Federal (GSA) Schedule GS-21F0031T

WB Newsletter

WB | Clinical

WB | Clinical 2017-11-07T13:45:45+00:00

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.

Services

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

Operations Support

  • Develop regulatory plan and submission

  • Confirm CGMP / GLP / GTP parameters

  • Provide oversight during design and construction

  • 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

Compliance Support

  • Identify equipment, conduct procurement, and oversee installation

  • Confirm ability to meet regulatory platforms necessary to operate

  • Support preparation for AAALAC accreditation

Projects

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