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
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