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The Strathprints institutional repository is a digital archive of University of Strathclyde research outputs.

Strathprints serves world leading Open Access research by the University of Strathclyde, including research by the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), where research centres such as the Industrial Biotechnology Innovation Centre (IBioIC), the Cancer Research UK Formulation Unit, SeaBioTech and the Centre for Biophotonics are based.

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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.