"Responsive, reliable and knowledgeable. Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"

Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

Preparation for pre-approval and routine regulatory inspections by global regulators

OBJECTIVES

Ensure readiness for external inspections in order to provide an accurate state of account and minimise risk of regulatory citation
Establish processes, skills and accountabilities for continuous inspection readiness

ROLE

Review current quality systems
Train client in regulatory expectations and inspection behaviour
Plan and execute compliance gap analysis (gap analysis, audit, review and interview)
Determine and prioritise gaps
Plan and manage remediation actions
Support preparation of regulatory communications
Support development of position papers to demonstrate current compliance status, risks and management plans
Provide frontline and backroom support during inspections
Support preparation of responses to regulatory queries and issues
Conduct mock inspections / audits to evaluate state of readiness throughout programme

OUTCOMES

Understanding of current compliance position and risks throughout client organisation
Resolution of high priority risks
Culture of continuous readiness established
Increased knowledge base and confidence during inspections
Greater preparedness for inspections, understanding of appropriate behaviours

CHALLENGES

BENEFITS