Services
Aggregate Safety Reports
Operations and Vendor Management
Operations and Vendor Management
Manage and author aggregate report projects in accordance with global regulatory requirements for all products pre-clinical to post-marketing.
Operations and Vendor Management
Operations and Vendor Management
Operations and Vendor Management
Establish safety report (ICSR) management and submission procedures. Provide oversight of pharmacovigilance service providers including selection and on-boarding.
Signal Detection and Risk Management
Signal Detection and Risk Management
Signal Detection and Risk Management
Comprehensive signal management from pre-clinical through post-marketing. Develop risk mitigation, minimization and management strategies and plans.
Audit and Inspection Readiness
Signal Detection and Risk Management
Signal Detection and Risk Management
Conduct formal audit assessments to determine compliance with global regulatory requirements for vendors or Sponsors. Prepare your team and systems for regulatory agency inspections. Perform process gap analysis and SOP authoring.