Services

We provide expertise to innovators and investors on:

• Review or development of your strategic mission, vision, and values
• Internal competency or outsourcing assessments
• Operational and Regulatory strategy for discovery, development, and production
• Market strategy
• Stage gate readiness assessment
• Data package evaluation
• Risk assessment and mitigation
• Periodic strategy reassessments
• Business scorecards and metrics

Whatever your development stage, we can help you with our experience in the following areas: 

• Operational and Regulatory tactics
• Study direction
• Project management
• Brokering expertise
• IND-enabling data assessments for new medicines 
  • Analytical chemistry
  • Absorption, Distribution, Metabolism, Elimination (ADME)
  • Drug-Drug Interaction (DDI)
• Vendor/Service Provider audits and relations
• Inspection support
• Quality best practice
• Process analysis and improvements
• Deviation investigations
• Corrective and preventative actions
• Laboratory start- and scale-up

We have helped other leaders and teams with the following deliverables: 

• Key Hires strategy
• Building trust relationships
• Succession planning
• Leadership assessment/training/coaching
• Skills development
• Interim leadership roles
• Change management
• Leading cross-functional and geographically separated teams