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 Groupe Athena to standardize and optimize their service and complaint handling process, while building an operating model and functional organizational structure to support their future growth objectives.
Groupe Athena provided consulting experience to augment the company’s internal Global Complaint Management team in the area of program support.
Groupe Athena formed an internal team at the client who was responsible for developing, maintaining, and integrating the program and working group plans, reporting progress to key decision makers, identifying and requesting additional resource requirements, and providing first-line quality assurance for program activities and deliverables.
Groupe Athena supported the team 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.