Skip to main content

Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies—Why and What?

Abstract

Purpose

The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries.

Methods

The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs.

Results

The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing regulatory affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company’s regulatory affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO.

Conclusions

This survey indicated that outsourcing in regulatory affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in regulatory affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2

References

  1. 1.

    Abodor H. Ethical issues in outsourcing: the case of contract medical research and the global pharmaceutical industry. J Bus Ethics. 2012;105:239–55.

    Article  Google Scholar 

  2. 2.

    Bates S, Sloan E. Outsourcing regulatory affairs activities: how a policy can drive good decisions. Drug Inf J. 2000;34:981.

    Google Scholar 

  3. 3.

    Clemens N. Outsourcing in drug development. Drug Dev. 2010;5:48.

    Google Scholar 

  4. 4.

    Contract Pharma: outsourcing survey 2014. http://www.contractpharma.com/issues/2014-04-02/view_features/2014-outsourcing-survey/#sthash.REjeKhze.dpuf. Accessed 13 May 2014.

  5. 5.

    Crossley R. The quiet revolution: outsourcing in pharma. Drug Discov Today. 2004;16:694.

    Article  Google Scholar 

  6. 6.

    Cutting edge information: regulatory affairs: safeguarding submission success and product development strategy, 2012. http://www.cuttingedgeinfo.com/research/regulatory/market-approval. Accessed 20 Jan 2013.

  7. 7.

    Drabu S, Gupta A, Bhadauria A. Emerging trends in contract research industry in India. Contemp Clin Trials. 2010;31:419–22.

    Article  PubMed  Google Scholar 

  8. 8.

    Kennedy T. Strategic project management at the project level. Clin Res Reg Aff. 2001;18:345–65.

    Article  Google Scholar 

  9. 9.

    Lowman M et al. Innovation risks of outsourcing in pharmaceutical new product development. Technovation. 2012;32:99–109.

    Article  Google Scholar 

  10. 10.

    Maat H, Lentz L. Improving the usability of patient information leaflets. Patient Educ Couns. 2010;80:113–9.

    Article  Google Scholar 

  11. 11.

    Mason J. Strategic alliances: partnering for success. Manag Rev. 1993;82:10.

    Google Scholar 

  12. 12.

    Miller L. Commentary: outsourcing of regulatory activities: how a policy can drive good decisions. J Drug Inf. 2000;34:987–9.

    Google Scholar 

  13. 13.

    Montpart Costa, E. Making the most of the EU’s regulatory resources. Regul Aff J: Pharma 2009; 20.

  14. 14.

    Patton MQ. Qualitative evaluation and research methods. 2nd ed. Newbury Park: Sage Publications; 1990.

    Google Scholar 

  15. 15.

    Pearce J. Why domestic outsourcing is leading America’s reemergence in global manufacturing. Bus Horiz. 2014;57:27–36.

    Article  Google Scholar 

  16. 16.

    Piachaud B. Outsourcing in the pharmaceutical manufacturing process: an examination of the CRO experience. Technovation. 2002;22:81–90.

    Article  Google Scholar 

  17. 17.

    Piachaud B. Outsourcing technology. Res Technol Manag. 2005;48:40–6.

    Google Scholar 

  18. 18.

    Quinn B. The outsourcing innovation: the new engine of growth. Sloan Manag Rev Summer. 2000;41:4.

    Google Scholar 

  19. 19.

    Sherlock A. Outsourcing: China takes center stage. Appl Clin Trials. 2012;28–31:33.

    Google Scholar 

  20. 20.

    Zirpoli F, Becker MC. The limits of designing and engineering outsourcing: performance integration and the unfulfilled promises of modularity. R&D Manag. 2011;41:21–43.

    Article  Google Scholar 

Download references

Conflict of Interest

The authors declare that they have no conflict of interest.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Anu Gummerus.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Gummerus, A., Airaksinen, M., Bengtström, M. et al. Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies—Why and What?. J Pharm Innov 11, 46–52 (2016). https://doi.org/10.1007/s12247-015-9235-4

Download citation

Keywords

  • CRO
  • Pharmaceutical industry
  • Regulatory affairs
  • Outsourcing