Building regulatory capabilities for pharmaceutical firms' internationalization

Author(s):  
Sudhir Yadav

PurposeThe internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.Design/methodology/approachThe research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulatory capabilities.FindingsTo manage regulatory requirements firms need knowledge related to plant approval and product registration. Firms have to submit dossiers to the respective country's regulatory authority to get plant approval and product registration. They can simultaneously apply for both to save time to enter the target market. The requirements for each market are unique in terms of format and contents for dossier preparation. Dossier preparation needs data from various departments which calls for good coordination among various functional areas, i.e. production, QA and QC, R&D, purchasing, etc. If the firm has operations in multiple markets and offers multiple products in a single market the regulatory function is separately organized for less regulated, semi‐regulated and regulated markets.Practical implicationsPharmaceutical firms targeting international markets can get insight into the regulatory requirements and the process to be adopted to build regulatory requirements.Originality/valueThe paper shows that firms use a systematic process to build capabilities for managing regulations. The paper also offers a process model for firms to build regulatory capabilities for internationalization.

2018 ◽  
Vol 24 (3) ◽  
pp. 495-518 ◽  
Author(s):  
Guillermo Ruiz-Pava ◽  
Clemente Forero-Pineda

Purpose This paper aims to develop the concept of internal search of ideas to show the contrast between search strategies adopted by firms that introduce new products into local and international markets. Design/methodology/approach Based on data from 2,652 innovative firms, the paper uses factor analysis to explore and confirm appropriate groups of sources of innovative ideas. The analysis differentiates between internal and two types of external sources. Logistic and bivariate regressions reveal different search strategies for innovation in local and international markets. Findings Firms reporting products new to international markets exhibit search strategies combining ideas from internal sources with ideas from other firms. Firms reporting products new to local market reveal a search strategy centered on ideas from other firms. Practical implications Managers and policymakers wishing to promote innovations for international markets should concentrate their resources on developing the organizations’ capacity to generate ideas internally while monitoring other firms’ ideas. Managers targeting local markets may focus their efforts on intelligence over ideas coming from other firms. Originality/value Clarifying the relationship between knowledge and ideas, the paper finds that search strategies of firms are more effective for innovation depending on the target market. Firms searching for ideas among other firms generate ideas that might trigger innovation in products new to local markets. Firms searching both for internal and external ideas generate ideas leading to products new to international markets.


2010 ◽  
Vol 44 (9/10) ◽  
pp. 1410-1436 ◽  
Author(s):  
İrem Eren Erdoğmuş ◽  
Muzaffer Bodur ◽  
Cengiz Yilmaz

PurposeThis study aims to develop and test a theoretical model to delineate the effects of target market characteristics, firm characteristics and strategic resources, and product characteristics on standardization decisions in brand management of emerging market firms. The effects of standardization on brand performance in international markets are also to be explored.Design/methodology/approachThe study develops a model based on the extant literature and tests its relevance through a survey of eligible managers in charge of international brand operations of 94 strategic business units in Turkey.FindingsThe empirical findings indicate that several factors exist as significant drivers of standardization decisions at various levels of brand management. Interestingly, even though firm characteristics and strategic resources were found to be the most critical drivers of brand performance, standardization versus adaptation approaches did not have any significant impact on strategic brand performance.Originality/valueThe study takes a standardization perspective to strategic brand management in international markets and tests it from the perspective of emerging markets.


2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Edward C. Tomlinson ◽  
Christopher A. Nelson ◽  
Luke A. Langlinais

Purpose This paper aims to investigate how the reparative efforts of extensive apologies, compensation and structural change affect trust after a violation has occurred. Specifically, this paper presents a cognitive process model positing that voluntary reparative efforts will shape the victim’s stability attributions for the cause of the violation such that it will be deemed less stable (i.e. unlikely to recur); as a result, the victim is more likely to perceive the transgressor as being fair, and hence extend subsequent trust. Design/methodology/approach Two experiments were conducted to test the cognitive process model. Findings The results of both experiments supported this predicted sequence for extensive apologies. Support for the predicted sequence was also found when compensation and structural change are invoked as reparative efforts. Originality/value This research has theoretical and practical implications for a more nuanced understanding of how causal attribution theory and organizational justice theory can be integrated within the context of trust repair.


2014 ◽  
Vol 21 (2) ◽  
pp. 83-97
Author(s):  
Arne Lindseth Bygdås

Purpose – The literature on knowledge transfer is dominated by a one-way transmission model logic where knowledge is captured and transferred from one source to another, assuming the source and receiver resemble each other and have some common knowledge. The social learning processes, what is learned and the phases and sequences of the developmental processes by which learning take place are more or less black boxed in the literature. This paper investigates the social dynamics of the formation and shaping of organizational practice from scratch in a greenfield organizational setting where no prior organizational practice exist. Design/methodology/approach – The paper builds on a case study approach applied in two greenfield organizational settings. A descriptive process model is developed to analyze the translocation and sociogenesis of organizational practices. Findings – A transfer-approach provides a too simplistic and narrow understanding of the process of “moving” organizational practices. Establishing an organizational practice can be described as a community of knowing “in the making” following various modes of cultural learning characterised by mutual adjustments, joint interactions, and alignment of shared understandings, and as such is more learned than transferred. Practical implications – The process model developed in the paper provides a platform for better understanding, planning and execution of intra-firm knowledge transfer and regeneration. Originality/value – The paper provides an in-depth empirical analysis of organizational practice generation from scratch emphasizing the social dynamics and co-construction of meaning when a collective capability is being acquired and built up.


2016 ◽  
Vol 22 (2) ◽  
pp. 146-170 ◽  
Author(s):  
John H. Humphreys ◽  
Milorad M. Novicevic ◽  
Mario Hayek ◽  
Jane Whitney Gibson ◽  
Stephanie S. Pane Haden ◽  
...  

Purpose The purpose of this study is to narratively explore the influence of leader narcissism on leader/follower social exchange. Moreover, while researchers acknowledge that narcissistic personality is a dimensional construct, the preponderance of extant literature approaches the concept of narcissistic leadership categorically by focusing on the reactive or constructive narcissistic extremes. This bimodal emphasis ignores self-deceptive forms of narcissistic leadership, where vision orientation and communication could differ from leaders with more reactive or constructive narcissistic personalities. Design/methodology/approach The authors argue that they encountered a compelling example of a communal, self-deceiving narcissist during archival research of Robert Owen’s collective experiment at New Harmony, Indiana. To explore Owen’s narcissistic leadership, they utilize an analytically structured history approach to interpret his leadership, as he conveyed his vision of social reform in America. Findings Approaching data from a ‘history to theory’ perspective and via a communicative lens, the authors use insights from their abductive analysis to advance a cross-paradigm, communication-centered process model of narcissistic leadership that accounts for the full dimensional nature of leader narcissism and the relational aspects of narcissistic leadership. Research limitations/implications Scholars maintaining a positivist stance might consider this method a limitation, as historical case-based research places greater emphasis on reflexivity than replication. However, from a constructionist perspective, a focus on generalization might be considered inappropriate or premature, potentially hampering the revelation of insights. Originality/value Through a multi-paradigmatic analysis of the historical case of Robert Owen and his visionary communal experiment at New Harmony, the authors contribute to the extant literature by elaborating a comprehensive, dimensional and relational process framework of narcissistic leadership. In doing so, the authors have heeded calls to better delineate leader narcissism, embrace process and relational aspects of leadership and consider leader communication as constitutive of leadership.


2017 ◽  
Vol 12 (1) ◽  
pp. 33-45 ◽  
Author(s):  
Abhigyan Sarkar ◽  
Juhi Gahlot Sarkar

Purpose Extant research shows that individual’s relationship with brand can be structurally similar to both interpersonal love relationship and religious relationship. A stream of consumer research states that individual can love a brand like a person loves another person. Another stream of consumer research postulates that individual can perceive brand equivalent to religion, and even substitute religion with brand. Research is scarce connecting these two different paradigms of brand relationship, given that interpersonal relationship is not necessarily as devotional as religious relationship. The purpose of this paper is to conceptualize the psychological process through which an individual can substitute his/her religion with brand. The basic theoretical premise of this substitution behaviour is the proposition that brand meanings can be perceived as equivalent to religious meanings. Design/methodology/approach This paper has conducted an integrative review of selected extant research related to individual-brand relationships, interpersonal relationships and religiosity. Findings This paper develops a consumer response hierarchy model showing the inter-related psychological processes through which an individual can substitute his/her religion with brand. The model forms the basis for the discussion of theoretical contributions and managerial implications. Originality/value The value of this conceptual paper lies in developing a process model for the first time in the area of consumer-brand relationship domain explaining the stage-wise psychological processes through which individual can move from mere cognitive brand satisfaction towards perceiving brand as substitute of religion.


2017 ◽  
Vol 6 (3) ◽  
pp. 290-314 ◽  
Author(s):  
Durga Prasad Gautam

Purpose Political economy research recognizes that the inflows of external financial resources help the governments enact market-oriented reforms. Since remittances have outpaced other types of financial inflows in many countries, they can potentially increase the government’s incentive to implement regulatory reform that can contribute to business-friendly environment. This issue has long been overlooked by the literature on remittances. The purpose of this paper is to examine whether remittances promote business regulatory reform in the recipient countries. Design/methodology/approach This study uses balance of payments data on remittances for 114 countries during 2004-2012 period. Since remittances could be endogenous to business regulation, the identification strategy follows an instrumental variable approach. The author assesses the general stability of linear model estimates by fitting the beta regression model. Findings The results show that, while the increase in remittance inflows is associated with lower regulatory requirements for starting a business in the recipient economy, this association is stronger in developing countries than in high-income nations. Various sensitivity tests reinforce the robustness of these findings. Originality/value One of the most important yet overlooked aspects of remittances is that they can potentially shape the political will to enact regulatory reform for businesses. The incentives for the government to relax burdensome entry regulations tend to stem from potential gains associated with the formalization of remittances. This paper makes a first attempt at studying the link between remittances and the quality of entry regulation.


2015 ◽  
Vol 12 (3) ◽  
pp. 314-329 ◽  
Author(s):  
S. M. Riad Shams

Purpose – It is recognised that reputation is a relational construct; however the impact of stakeholders’ various relational dimensions on their perceptions to influence reputation is not widely understood. The purpose of this paper is to add to the current understanding of stakeholders’ relationships, interactions, their subsequent relational dimensions and its impact on stakeholders’ perceptions to further influence relational reputation. Design/methodology/approach – This paper takes a case study approach. Findings – The findings of this study recognise the impact of relationship marketing (RM) on the influence of stakeholders’ perceptions. It discusses how RM substantiate the pertinent authenticity (symbolises reputation), relevance and differentiation (represent brand positioning) of an organisation’s profile and/or their market offerings, in relation to the interest of the target market through the cause and consequence of stakeholder relationships and interactions to influence their perceptions. The findings acknowledge 11 RM dimensions that have relational implications to nurture stakeholders’ perceptions and subsequent relational reputation, which appear viable across industries and markets. Originality/value – Underlying the cause and consequence of stakeholder relationships and interactions; these 11 RM dimensions emerge as antecedents to form/reform relational reputation. Further academic and professional implications of the findings are briefly discussed.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Subimal Chatterjee ◽  
Debi P. Mishra ◽  
Jennifer JooYeon Lee ◽  
Sirajul A. Shibly

Purpose Service providers often recommend unnecessary and expensive services to unsuspecting consumers, such as recommending a new part when a simple fix to the old will do, a phenomenon known as overprovisioning. The purpose of this paper is to examine to what extent consumers tend to defer their decisions should they suspect that sellers are overproviding services to them and they cannot prevent the sellers from doing so (they lack personal control); and how proper market signals can mitigate such suspicions, restore personal control and reduce deferrals. Design/methodology/approach The paper conducts three laboratory experiments. The experiments expose the participants to hypothetical repair scenarios and measure to what extent they suspect that sellers might be overproviding services to them and they feel that they lack the personal control to prevent the sellers from doing so. Thereafter, the experiments expose them to two different market signals, one conveying that the seller is providing quality services (a repair warranty; quality signal) and the other conveying that the seller is taking away any incentives their agents (technicians) may have to overprovide services (the technicians are paid a flat salary; quantity signal). The paper examines how these quality/quantity signals are able to reduce overprovisioning suspicions, restore personal control and reduce decision deferrals. Findings The paper has two main findings. First, the paper shows a mediation process at work i.e. suspecting potential overprovisioning by sellers leads consumers to defer their decisions indirectly because they feel that they lack personal control to prevent the sellers from doing so. Second, the paper shows that the quantity signal (flat salary disclosure), but not the quality signal (warranty), is able to mitigate suspicions of overprovisioning, restore personal control and reduce decision deferrals. Practical implications The paper suggests that although buyers may rely on quality signals to assure them of superior service, these signals do not guarantee that the quantity of service they are receiving is appropriate. Therefore, sellers will have to send a credible quality signal and a credible quantity signal to the consumers if they wish to tackle suspicions about service overprovision and service quality. Originality/value The paper is original in two ways. First, the paper theorizes and tests a mediation process model whereby quality/quantity signals differentially mitigate overprovisioning suspicions, restore personal control and reduce decision deferrals. Second, the paper speaks to the necessity of expanding the traditional signaling literature, designed primarily to detect poor quality hidden in the products/services of lower-quality sellers, to include detecting/solving overprovisioning often hidden in the services provided by higher-quality sellers.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Mahmoud Ershadi ◽  
Marcus Jefferies ◽  
Peter Rex Davis ◽  
Mohammad Mojtahedi

PurposeThe purpose of this study is twofold: first, to identify major project management (PM) complexities in principal construction contracting; and second, to study the contribution of project management offices (PMOs) to addressing such complexities.Design/methodology/approachA two-stage research design was adopted through a structured literature review (SLR) and a qualitative survey study.FindingsThe two-stage study resulted in mapping out the contribution of 10 functional areas to 15 complexity factors that were retrieved from the literature and categorized using the TOE (technical, organizational and environmental) framework. Six outcomes including (1) facilitated processes, (2) improved decisions, (3) improved coordination, (4) enhanced alignment, (5) addressed uncertainties and (6) integrated oversight were identified that describe how PMOs can contribute to tackling complexities.Research limitations/implicationsSimilar to other qualitative studies, this study has some limitations in terms of the replicability of results. Regarding the exploratory nature of this study to explain the contribution of PMO to complexity, further quantitative surveys can be conducted using a larger sample to statistically examine the significance of proposed relations between capabilities and complexity factors.Practical implicationsThis study provides an understanding of the contribution of PMOs to tackling ever-increasing complexities embedded in construction contracting. The authors suggest requirements to be considered by professionals toward overcoming such complexities.Originality/valueAlthough prior studies have separately investigated PMO functions and PM complexities, this study explores the link between these two spheres to discuss one important application of PMO in this context.


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