Services

Planning and Strategy

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
  • Gap analyses
  • Risk assessment and mitigation
  • Periodic strategy reassessments
  • Business scorecards and metrics
  • SBIR/STTR technical support

Operations and Outsourcing

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

Leadership and Development

We have helped other leaders and teams succeed through:

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

Expert Witness Services

We provide services to clarify the complex science, technology, quality, and regulatory aspects of medical product discovery, development, and manufacturing.

  • Clear expert opinions for medicine and medical device cases
  • Quality, regulatory, and cGMP expertise for legal discovery
  • Declarations, affidavits, reports, depositions, and testimony

About Our President

Katrina Rogers

Katrina Rogers is a change expert with over 24 years of experience in the discovery, development, and manufacture of medicines and related technology. An expert in laboratory and technical operations, she is also an ASQ certified Manager of Quality/Organizational Excellence and Pharmaceutical GMP Professional. Her professional services firm specializes in dramatically decreasing the cost and time of bringing new therapies to market.