Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Benefits and success of outsourcing in DRA

Christiane Metje (Abschlußjahr: 2016)

Summary
Language: English
Commonly, thinking about the term outsourcing it is usually associated with production sites transferred from Germany or Europe (high wage countries) to countries where the labour expenses as well as the costs for goods, facilities etc. are far below those of the origin countries. Nonetheless, not all outsourcings come along with job cuts or at least job shifts. Hence, most outsourcings are recognized hardly as such until they are named. Especially in Regulatory Affairs, it is utilized largely to cover peak workloads or in case, special expertise is required and not available in-house. Therefore, the majority of outsourcings are no big projects but single supports of a few people or small teams. Often these supports are performed onsite with the company in need of support although in the modern IT-dominated times they could as well be performed offsite. Up to now, the big projects for outsourcing in Regulatory Affairs often circle around the subdivision of publishing which is obvious, as these tasks do not need much of the expertise that is gained exclusively for processes and products internally. The full responsibility in Regulatory Affairs, including process and product knowledge is handed to a vendor less often.
This master thesis provides an insight in a full outsourcing project in Regulatory Affairs. It describes a fictional set-up in which a pharmaceutical company wants to hand over some of its work in Regulatory Affairs. What is the best way to find a suitable vendor for the company's specific needs? What are the framework requirements for such cooperation? These and further questions are answered. Special focus is on a general vendor evaluation to identify the most suitable candidate. The analysis incorporates the framework requirements by the company and discusses the benefits of a respective vendor. In addition, performing a stakeholder analysis shows the interested and involved parties and their view onto the outsourcing. Once a vendor is identified, the cooperation needs to be animated which is described in a concrete example. Such a strategic and long-term project aims, of course, on the successful interaction of the company with the vendor. Therefore, the model structure includes, from governing body to team leads, representatives from both parties for each function – company and vendor are running as tandems. In contrast to outsourcing of publishing activities, the handover of the knowledge on processes and product is crucial. Thus, a significant focus is on the communication within the pharmaceutical company itself and in the team of the vendor, as well as between both sides. After initiation of the cooperation, it can be determined if such an outsourcing project is running smoothly through commensurable key performance indicators that were defined during the project design. After the project is implemented completely into the company’s procedures and a steady state of the project is achieved, ideas arise how it can be amplified further.
Overall, the hand-over of full Regulatory Affairs responsibility to a vendor can be, with a thorough planning at the beginning, a very beneficial liaison for both involved parties. The common prejudices of job cut and cost reduction can be refuted due to a gain in expertise and flexibility.
Pages: 42 pages
Annexes: 3 pages