Managing regulatory compliance

The issue

A major specialty pharmaceutical and medical products manufacturer identified a need to improve inconsistent handling of service and complaint issues related to their marketed products. From both regulatory and business liability perspectives, it is critically important to pharmaceutical and medical device companies that they have robust and compliant drug safety monitoring processes. The company sought help from PricewaterhouseCoopers’ Pharmaceutical and Life Sciences Advisory Services group to standardise and optimise their service and complaint handling process, while building an operating model and functional organisational structure to support their future growth objectives.

Our approach

PricewaterhouseCoopers provided consulting experience to augment the company’s internal Global Complaint Management team in the area of programme Management Office (PMO) support. Our approach was based on our global “Performance Improvement Through Benefits Management” (PITBM) methodology. The methodology is intended to guide organisations through the tasks and activities needed to achieve successful process improvement and the full realisation of planned business outcomes and benefits.

The outcome

PricewaterhouseCoopers programme management personnel integrated with dedicated resources from the client to form the PMO staff and drive the overall initiative and goals. The PMO was responsible for developing, maintaining, and integrating the programme and working group plans, reporting progress to key client decision makers, identifying and requesting additional resource requirements, and providing first-line quality assurance for programme activities and deliverables.

PricewaterhouseCoopers supported the PMO by developing and maintaining project plans, preparing agendas and updates, developing reference materials, facilitating and coordinating working sessions, documenting working group meeting progress and work products, assuring timely issue resolution, and assisting with the preparation of deliverables. PricewaterhouseCoopers also provided support for the company working groups via subject matter experience in organisational change and redesign, drug and device safety, regulatory compliance, and vendor contract management.