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Services

Clinical and Nonclinical Inspection Readiness

  • Inspection management system design and training

  • GxP Training

  • Risk assessments and gap analyses

  • Subject matter expert interview preparation

  • TMF readiness

  • Clinical investigator site training and preparation for inspection

  • Support inspections at vendors or partners

Controlled Documents and Learning Management

  • Develop Standard Operating Procedures (SOPs), Policies, Plans, Forms, Manuals, Templates

  • Learning management system design and training

  • Develop training curriculums 

  • Training effectiveness risk evaluations

Vendor Qualification and
Routine Assessment

  • Vendor management system design and training

  • Audit scheduling and tracking

  • Approved supplier tracking

  • New vendor/service qualification

  • Vendor issue management

  • Vendor disqualification 

Contact Me

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