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 journalArticle

1 Citation (Scopus)

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.
LanguageEnglish
Pages29-50
Number of pages21
JournalInternational Journal of Entrepreneurship and Innovation
Volume7
Issue number1
DOIs
Publication statusPublished - 2007

Fingerprint

Biotechnology
Drug products
Industry
Small and medium-sized enterprises
Exploratory study
Pharmaceuticals
Standardization
Costs

Keywords

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

Cite this

@article{986c977f69f74932a80d98b42f6f529c,
title = "The impact of regulatory affairs on biotechnology and pharmaceuticals SMEs : an exploratory study of e-submissions",
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.",
keywords = "biotechnology, pharmaceuticals, regulatory affairs, e-submissions, high-tech SMEs, small-and medium-sized enterprises, technology adoption, product development",
author = "S.Y. Cooper and C. Bottomley",
year = "2007",
doi = "10.1504/IJEIM.2007.012172",
language = "English",
volume = "7",
pages = "29--50",
journal = "International Journal of Entrepreneurship and Innovation",
issn = "1465-7503",
number = "1",

}

The impact of regulatory affairs on biotechnology and pharmaceuticals SMEs : an exploratory study of e-submissions. / Cooper, S.Y.; Bottomley, C.

In: International Journal of Entrepreneurship and Innovation , Vol. 7, No. 1, 2007, p. 29-50.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The impact of regulatory affairs on biotechnology and pharmaceuticals SMEs : an exploratory study of e-submissions

AU - Cooper, S.Y.

AU - Bottomley, C.

PY - 2007

Y1 - 2007

N2 - 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.

AB - 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.

KW - biotechnology

KW - pharmaceuticals

KW - regulatory affairs

KW - e-submissions

KW - high-tech SMEs

KW - small-and medium-sized enterprises

KW - technology adoption

KW - product development

UR - http://dx.doi.org/10.1504/IJEIM.2007.012172

U2 - 10.1504/IJEIM.2007.012172

DO - 10.1504/IJEIM.2007.012172

M3 - Article

VL - 7

SP - 29

EP - 50

JO - International Journal of Entrepreneurship and Innovation

T2 - International Journal of Entrepreneurship and Innovation

JF - International Journal of Entrepreneurship and Innovation

SN - 1465-7503

IS - 1

ER -