877-6GR-OUP6 or 877-647-6876info@groupeathena.comPharmaceutical Consultants Serving: USA - India - South East Asia

Case Studies

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Case Study One

A medical device manufacturer had a failing QC testing group though group facilities in Europe had a higher rate of productivity and much higher rate of efficiency in terms of fewer laboratory investigations and samples analyzed.

The project was to analyze the situation and produce a new laboratory solution to establish at least parity with the European laboratory.

The Process:

Both laboratories were assessed using PERT/CPM tools and the results were process mapped to discover the differences between the laboratories. Following this process the analytical laboratories were reviewed for similarities and an optimum process was developed for the process going forward.

With the optimum process in place a gap analysis was developed and a forward implementation plan was crafted. Part of the solution was a total redesign of the analytical laboratory as well as an upgrade of the operating practices.

Outcome:

The result of the project was a vastly improved operating situation with reduced laboratory investigations and an improved level of productivity and operating efficiency.

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Case Study Two

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 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.

Our Approach

Groupe Athena provided consulting experience to augment the company’s internal Global Complaint Management team in the area of program support.

The Outcome

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.

Case Study Three

An acquisition of a generic pharmaceutical company by a rival resulted in an order that required the divestiture of 3 products to a third party acquirer.

The responsibility of Groupe Athena was to act as the overseer for the divestiture to review: (1) the transfer of product, technology and marketing information, (2) the implementation of the technology by the acquiring company and (3) the subsequent verification that the client did not have access to the Confidential Business Information.

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