Services : Overall Process


Even the most advanced scientific approaches and well devised strategies depend on operational excellence and functional support. Our company offers the following services to develop or refine your safety organization:

Workflow design

We can design or re-engineer an overall single case workflow that is adaptable to different case types and case volumes or review existing process steps for efficiency, compliance, and practicality.

Labeling and Core Safety Information

Based on ongoing safety review or health authority requests we can prepare, review, and update USPIs, SmPCs and company core safety information. We write justification documents or perform labeling harmonization as requested.

SOP Writing and Review

We can review your existing SOPs, Working Practices or internal guidance documents for completeness, compliance, and practicality. We identify gaps and propose solutions as requested.

Safety Issue Escalation and Communication Plans

We develop or review your existing processes for adaptability and efficiency. We propose solutions for improvement. Topics may include differentiation based on product level or signal strength, timelines, decision making forum and responsibilities.

Audit and Inspection Preparation

We can develop or review plans, documentation and actual processes as well as provide training for Inspection readiness. Topics may include Types of inspections, interaction with Inspectors, staff awareness, or location preparation.

Right Sizing Safety Organizations
(budget, full time/contractor/vendor assessment)

We review current or proposed organizational models, strategies, volumes, and complexities and suggest solutions. Specific aspects may include employee competencies, budget considerations, risk tolerance, and quality issues.