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

S.Y. Cooper, C. Bottomley

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


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.
Original languageEnglish
Pages (from-to)29-50
Number of pages21
JournalInternational Journal of Entrepreneurship and Innovation
Issue number1
Publication statusPublished - 2007


  • biotechnology
  • pharmaceuticals
  • regulatory affairs
  • e-submissions
  • high-tech SMEs
  • small-and medium-sized enterprises
  • technology adoption
  • product development


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