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The impact of regulatory affairs on biotechnology and pharmaceuticals SMEs : an exploratory study of e-submissions

Cooper, S.Y. and Bottomley, C. (2007) The impact of regulatory affairs on biotechnology and pharmaceuticals SMEs : an exploratory study of e-submissions. International Journal of Entrepreneurship and Innovation, 7 (1). pp. 29-50. ISSN 1465-7503

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Abstract

This paper is focused on potentially mandatory electronic submissions (e-submissions) to regulatory authorities for the approval of biotechnology and pharmaceuticals products. Such developments will have serious implications for Small- and Medium-sized Enterprises (SMEs) because the cost of establishing e-submission infrastructures could be expensive, disruptive and prohibitive. Although the industry agrees that financial benefits accrue from e-submission via 'speed-to-market' activities, research (Hunter Centre for Entrepreneurship @ Strathclyde (HCE), 2004) shows that widespread mandatory e-submissions are limited but growing, however, industry and regulatory stakeholders wish to make standardisation of submissions a key objective. Few SMEs are considering e-submission and are more likely to license successful Research and Development (R&D) to large companies to reduce the development risks involved. Interventions at Government level will be vital to maintain the competitiveness of the biotechnology and pharmaceuticals sectors and such initiatives ensure that SMEs reap the benefits that e-submission can generate. Innovative and workable initiatives are suggested to assist biotechnology and pharmaceuticals SMEs in dealing effectively with e-submissions.

Item type: Article
ID code: 9766
Keywords: biotechnology, pharmaceuticals, regulatory affairs, e-submissions, high-tech SMEs, small-and medium-sized enterprises, technology adoption, product development, Management. Industrial Management
Subjects: Social Sciences > Industries. Land use. Labor > Management. Industrial Management
Department: Strathclyde Business School > Hunter Centre For Entrepreneurship
Related URLs:
    Depositing user: Strathprints Administrator
    Date Deposited: 15 Mar 2010 12:21
    Last modified: 04 Sep 2014 20:46
    URI: http://strathprints.strath.ac.uk/id/eprint/9766

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