alexa Abstract | Values and Disadvantages of Outsourcing the Regulatory Affairs Tasks in the Pharmaceutical Industry in EU Countries
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article Open Access


Background: The purpose of this study was to determine the values and disadvantages of outsourcing regulatory affairs tasks in the pharmaceutical industry. The aim was also to study how many CROs the pharmaceutical companies outsource regulatory affairs tasks to and the duration of outsourcing partnerships between companies and CROs. Method: The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany and Spain focusing on those companies that undertake regulatory affairs. Results: The survey received 71 completed responses out of 147, a response rate of 48%. According to the responses, 65% of the pharmaceutical companies have outsourced tasks related to research and development over the last three to five years. Over 44% of the respondents informed that they have outsourced to one or two CROs only. One quarter of the respondents have outsourced to three to five CROs. Most (91%) of the respondents in the pharmaceutical industry strongly agree and agree on the fact that they outsource the regulatory affairs tasks because they want to obtain greater flexibility. The companies evaluated that outsourcing to CROs is expensive (strongly agree or agree 74%). Conclusion: CROs have to keep the qualitative level high and obtain flexibility towards the companies. When a company is considering outsourcing regulatory tasks, planning has to be done well in advance. The main topics to be discussed between the company and CRO before outsourcing process are the estimated costs of the outsourcing, outsourcing strategy, information flow and audittrails.

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Author(s): Gummerus A, Airaksinen M, Bengtström M and Juppo A


CRO, Regulatory affairs,Outsourcing, Pharmaceutical industry, Regulatory affairs, British regulatory guidelines, Japan regulatory guidelines, Europian regulatory guidelines

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