A leading global medical diagnostic company sought to optimally structure and effectively resource its global Regulatory Affairs & Pharmacovigilance (RA&PV) function.
Key objectives were to enable improved timeliness and quality of regulatory submissions in both mature and emerging markets, leading to faster and better approvals.
The company also wished to understand the regulatory capabilities of the function in comparison with other leading life sciences organizations.
Kinapse undertook a detailed diagnostic analysis with key internal and external stakeholders across regions including the US, EU and Asia-Pacific.
Organizational options were developed supported by robust qualitative analysis.
A new, scalable organization structure was recommended to ensure strategic alignment as well as operational efficiencies.
A flexible resource model was developed to ensure resource adequacy, informed decision-making and transparent allocation.
Kinapse conducted a comprehensive benchmarking exercise to analyze the group’s regulatory capabilities against industry best practice.
Improved regulatory support to development projects delivering better regulatory approvals.
Enhanced regulatory intelligence and proactive health authority relationship management.
Ongoing full regulatory compliance across an expanding portfolio.