Medical/Regulatory/Legal Review Operations

TGaS Advisors helps life sciences companies improve the efficiency and effectiveness of their Medical/Regulatory/Legal (MRL) review process.

• MRL Review Process Benchmark

  Optimize your MRL review process, technology and roles.

  Key Areas

  All aspects of your MRL review process capability

  Areas of Focus

  • Planning and forecasting
  • Submission and prioritization
  • Offline/live review
  • Performance metrics and analysis
  • Training excellence
  • System requirements and functionality
  • Team structure and resourcing
  • Governance

  Deliverables

  Detailed comparative analysis to help you:

  • Reduce overall cycle time for review
  • Reduce number of review iterations
  • Achieve cost savings (e.g., agency costs)
  • Improve quality of review, and of review outputs
  • Improve adherence and compliance
  • Improve overall stakeholder and customer satisfaction
  • Grow review team capacity
  • Optimize system capabilities
• MRL Review Meeting Observation & Optimization

  Drive meeting preparedness, efficiency and decision-making.

  Key Areas

  MRL review meeting

  Areas of Focus

  • Meeting facilitation and management
  • Preparedness of meeting participants
  • Collaboration and solutions orientation
  • Clarity of participant roles
  • Empowerment and decision-making
  • Virtual meeting effectiveness
  • Overall meeting effectiveness

  Deliverables

  • Ratings on the management and effectiveness of the meetings (including industry comparison)
  • Observations and actions to consider on meeting management/facilitation, teamwork, collaboration and overall effectiveness
  • Identification of training opportunities
• End-to-End Promotional Asset Lifecycle Benchmark

  Integrate and optimize your promotional asset lifecycle for transformational business impact.

  Key Areas

  All aspects of planning, creation, Medical/Regulatory/Legal review, production, delivery and overall management of promotional assets from concept to expiration

  Areas of Focus

  • Planning and creation of promotional assets: brand planning through concept review
  • MRL review process: submission through approval
  • Production and delivery of promotional assets: print/digital production and fulfillment through expiration
  • Stakeholder engagement at all points

  Deliverables

  • Detailed comparative analysis of resources, processes, capabilities and organizational strategies with insights and recommendations
  • Stakeholder and staff perspectives on what’s working and what’s not
  • Insights and recommendations to help you achieve measurable business impact
• Medical Content Approval Benchmark

  Optimize your capabilities related to medical/scientific material approval.

  Key Areas

  All aspects of your approval process for medical/scientific content in the US and globally

  Areas of Focus

  • Process optimization
  • Medical content management
  • Technology
  • Metrics and analysis
  • Training
  • Structure and resourcing
  • Scope of materials and required level of review

  Deliverables

  • Detailed comparative analysis of resources, processes, capabilities and organizational strategies
  • Stakeholder and staff perspectives on what’s working and areas for improvement
  • Insights and recommendations to help you achieve measurable business impact in time/efficiency, capacity, satisfaction and quality