"QUALITY IS NEVER AN ACCIDENT; IT IS ALWAYS THE RESULT OF HIGH INTENTION, SINCERE EFFORT, INTELLIGENT DIRECTION AND SKILLFUL EXECUTION; IT REPRESENTS THE WISE CHOICE OF MANY ALTERNATIVES."

quality

  • QMS implementation, remediation, upgrades

  • Risk Management

  • CAPAs

  • Audit Execution

  • Training

REGULATORY

  • Regulatory Strategies

  • Submissions

  • Remediation

  • Regulatory Compliance

  • EU MDR Transition

technical services

  • Technical writing

  • Validation, Verification and Qualification Plans

  • Statistical Analyses

  • Test Laboratory Sourcing

clinical

  • Site Qualification

  • Monitoring

  • Auditing

  • TMF Preparation and Maintenance

project management

  • Project Planning

  • Plan Execution

  • Resource Management

  • Mentoring