Katrina's Services
Empowering others
I empower others to achieve their big ideas. The way I empower others is by listening to ideas, asking challenging questions, and building teams. I excel in leader, talent, product, and ecosystem development.
Specialties
Take your big ideas and make them a reality.
Katrina Rogers is a change expert with over 25 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.
Talent Development
Acquisition, development, and retention of top talent is the top challenge for many companies. We can help you with:
- Role knowledge, skills, and abilities assessments
- Position description updates
- Succession planning
- Training
- Employee Value Proposition evaluation
- Employee role-switching for skill development
- Internships for employee diversity
Leadership 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
Product Development
There is no single path from discovery to commercialization for medical products. Call us for help on:
- Go-to-market investigations
- Regulatory strategy and pathway determination
- Stage-gate readiness assessment
- Internal competency evaluation
- Contract Service Partner selection
- Study direction and project management support
- Expert witness services
Ecosystem Development
Collaborating to build an industry ecosystem isn’t a job for the fainthearted. Katrina has direct experience with:
- Strategic vision and core direction incubation
- Business model refinement
- Stakeholder engagement
- Multi-sector partnerships
- Innovation Cluster leadership
Additional
Services
Planning & 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 & 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
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