Specializing in Pharmacovigilance and Risk Management operations, our consultants design tailored solutions to meet your organizational needs to achieve the next level of performance.
Trends and new technology adoption
Compliance management and assurance
Process efficiency and effectiveness
Business Transformation Consulting
Our proven methodology allows us to establish and improve day-to-day operations in areas of:
Organizational design and governance
Merger and acquisition integration
Divestments or restructuring
Complex licensing arrangement
Process design and implementation
Launching or acquiring a new product
New market entry
Strategic planning and execution
Pharmacovigilance Quality System development and implementation
Company maturity assessment and Industry benchmarking
Technology Implementation Consulting
Introducing and implementing the right technology to support business needs and drive efficiency.
Tool selection and implementation
New technology and technical upgrades adoption
System automation opportunities to reduce cost and increase quality
Business case to examine ROI
Risk Management Consulting
Reinforcing, managing and improving compliance through risk management process governance, design and implementation.
Learning where operations are 'exposed'
Audit and inspection readiness
Defining and implementing CAPAs for inspection and audit findings
Ensuring compliance during a merger or acquisition
Maintaining compliance amidst resource constraints
Developing risk-based approaches
Pharmacovigilance and Risk Management Consultants
Business transformations begin with our deep understanding of Pharmacovigilance and Regulatory business needs and continue with our very hands-on and comprehensive approach to project delivery.
Our consultants bring a wealth of Pharma, CRO and Regulatory industry experience, analytical capabilities and a pragmatic mindset to drug safety and risk management challenges.
Ranging from short, consultative engagements to multi-year strategic transformations, our Global Business Transformation team will design the right solution to meet your needs.