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.

Assessment of country readiness for drug development: A qualitative study in Indonesia

“…In order for Indonesia to maximize returns from drug development, it needs to have access to sufficient capital to share risk and costs. Having advanced manufacturing technologies for drugs available, coupled with an increase in the number of specialized experts may allow outsourcing companies to offer contract services (i.e., R&D) and manufacturing support to overcome these challenges (Gummerus et al, 2016; Howells et al, 2012; Kaitin, 2010; Vikić‐Topić, 2005). Additionally, regulatory forces are expected to have a direct effect on drug development by granting approval in a timely manner (time to market).…”

The Outsourcing Strategic Fit and Partnership Relations in Thai Pharmaceutical Manufacturing

“…Researchers, at present, embrace a more comprehensive and broader scope of the dimensions of success and employ two-actor models to investigate the factors of success in addition to the overlap bet ween the outsourcing pair's views of success, as well as the trade-offs (Gunasekaran et al, 2015;Schwarz, 2014). At present, more work has been performed to understand the internal and external factors of both the outsourcer companies (CPOcontract provider organization), and their outsourcing companies, either CRO (contract research organization), CMO (contract manufacturing organization) or CDMO (contract development and manufacturing organization) (Gummerus et al, 2016). Due to heightened competitive and uncertain business environment, many companies have formed partners to survive.…”

“…What we have learned is quite similar to what Kedia and Lahiri (2007) has highlighted to us that the first generation outsourcing is not a true partnership model, it is only a strategic outsourcing model focusing on collaboration contracts, whereas the second and third generations is a true one. We thus further studied on the papers by Ali and Khan (2016), Festel et al (2014), Gummerus et al (2016), Khan and Ali (2015), Kinnula (2006), Lambert et al (2004), and Lane and Lum (2011) focusing on the similarities and difference between these two models. We have learned that the major reasons or aims for outsourcing are cost savings, free management time, access to specialist expertise, improved quality of service, to achieve flexibility in taking strategic business decision, in house resources unavailability and enhanced financial control, under the obligation of formally written contract; and the success of outsourcing in win-win position can be seen from matching of both internal and external factors between the outsourcer companies (CPOcontract provider organization), and their outsourcing companies, either CRO (contract research organization), CMO (contract manufacturing organization) or CDMO (contract development and manufacturing organization).…”

“…As a result, the relationship study will be the study of the correlation and/or association between the four factors and the 3 types of the strategic outsourcing fit and the partnership model. Moreover, based on the aforementioned literature above (Ali and Khan, 2016;Festel et al, 2014;Gummerus et al, 2016;Khan and Ali, 2015;Kinnula, 2006;Lambert et al, 2004;and Lane and Lum, 2011), there are additional factors to heighten the quality or to ensure longevity of outsourcing strategic fit and partnerships such as effective and timely communication, cross cultural understanding and cultural distances, trust, organizational proximity, cooperation and collaboration, revenue, and growth. It implies that those additional factors can be moderators that moderate either one of the two model fits or both, and can improve both the drivers and quality of the partnership models.…”

Values and Disadvantages of Outsourcing the Regulatory Affairs Tasks in the Pharmaceutical Industry in EU Countries

“…This paper is the second part of a survey done in the EU. The first part of the survey covered the questions why and what regulatory affairs tasks are being outsourced [15].…”