Picture of athlete cycling

Open Access research with a real impact on health...

The Strathprints institutional repository is a digital archive of University of Strathclyde's Open Access research outputs. Strathprints provides access to thousands of Open Access research papers by Strathclyde researchers, including by researchers from the Physical Activity for Health Group based within the School of Psychological Sciences & Health. Research here seeks to better understand how and why physical activity improves health, gain a better understanding of the amount, intensity, and type of physical activity needed for health benefits, and evaluate the effect of interventions to promote physical activity.

Explore open research content by Physical Activity for Health...

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

Full text not available in this repository. Request a copy from the Strathclyde author

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.