JPCC Associates
JPCC ASSOCIATES is a global team of pharmacovigilance experts providing strategic and operational solutions for drug safety and PV needs. With over 100 years of combined experience, they focus on customizing effective business solutions, ensuring compliance, and enhancing patient safety across the pharmaceutical industry.
Industries
Nr. of Employees
small (1-50)
JPCC Associates
Fort Collins, Colorado, United States, North America
Products
Audits and Inspection Readiness
Gap analysis, mock inspections, efficiency metrics and compliance monitoring, operational and leadership assessment, and remediation planning.
Key Focus on Patient Safety
Capturing all sources of safety information, establishing end to end safety signal management, and risk management prioritization.
Establishing PV Organizations
End to end pharmacovigilance groups with processes and supporting SOPs, covering operations, technical and medical safety.
Supporting Corporate Strategy
Strategic guidance from development to market, expansion from local to global markets, and outsourcing solutions.
Audits and Inspection Readiness
Gap analysis, mock inspections, efficiency metrics and compliance monitoring, operational and leadership assessment, and remediation planning.
Key Focus on Patient Safety
Capturing all sources of safety information, establishing end to end safety signal management, and risk management prioritization.
Establishing PV Organizations
End to end pharmacovigilance groups with processes and supporting SOPs, covering operations, technical and medical safety.
Supporting Corporate Strategy
Strategic guidance from development to market, expansion from local to global markets, and outsourcing solutions.
Services
Consulting to design and implement end-to-end pharmacovigilance groups including processes, SOPs, governance, and resource models.
Strategic PV support from development to market including global expansion planning, licensing support, outsourcing strategies and transaction (merger/de-merger) support.
Gap analysis, mock inspections, remediation planning, compliance monitoring and readiness preparations for regulatory inspections.
Capture and integrate safety information sources, implement signal detection workflows, and support risk management and prioritization activities.
Consulting to design and implement end-to-end pharmacovigilance groups including processes, SOPs, governance, and resource models.
Strategic PV support from development to market including global expansion planning, licensing support, outsourcing strategies and transaction (merger/de-merger) support.
Gap analysis, mock inspections, remediation planning, compliance monitoring and readiness preparations for regulatory inspections.
Capture and integrate safety information sources, implement signal detection workflows, and support risk management and prioritization activities.
Expertise Areas
- Pharmacovigilance system setup and governance
- Clinical safety and case management (ICSRs)
- Signal detection and safety analytics
- Regulatory compliance and reporting
Key Technologies
- Electronic safety database systems
- Electronic safety report submissions (E2B-standard reporting)
- Medical coding dictionaries and coding maintenance
- Signal detection and safety analytics methods