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Assessing the Regulatory Outsourcing Readiness

Whether to outsource some or major operational regulatory activities or functions is often a business decision based on the business case. Companies may decide to retain or outsource activities or functions based on company’s internal IT and information security policies (whether they want to allow external partner manage the data) and risk vs benefit analysis where cost saving is a factor.

Outsourcing, however, also requires an organization to be ready to work with external partner with right process, tools, governance structure to begin with; so that they can monitor and engage with partner efficiently.

Outsourcing can be planned as,

  • Product based outsourcing, where, end to end responsibilities of one or more products are given to external partner under project governance structure

  • Geography based outsourcing, where, end to end responsibilities of all products in partner country or region is given to external partner

  • Functional outsourcing, where activities or entire functional responsibilities are managed by external partner under company’s oversight. These include, variations dossier preparation and management, CMC and change control, publishing and submissions, labelling, artwork, regulatory information management, regulatory intelligence, vendor coordination, quality checks etc.

Key parameters that indicate company’s readiness for outsourcing include,

  • Standardized processes, data, and nomenclature: Harmonization of processes across regions where company’s regulatory teams are based helps yield better results from outsourcing right from smooth transition of work to new teams and everyday management of work. Similarly, harmonized data, nomenclature across teams helps streamline the outsourcing process.

  • Technology enabled centralization of data and documents, integrated with centralized review and approval process leads to seamless integration of external partner in the existing regulatory workflow.

  • Distinguished centralized and localized functions. Since several regulatory activities are required to be performed locally, identification of those local activities as well as centralized activities help in,

    • Identifying the right partner based on their functional and regional expertise

    • Transfer responsibilities based on activities

    • Integrate within centralized and regional workflow

Based on the assessment above, some of the questions that regulatory departments within companies can implore while assessing potential outsourcing strategy are,

  • What are the risks and benefits of outsourcing one or more products?

  • What are the risks and benefits of outsourcing regional activities?

  • What are the risks and benefits of outsourcing specific functional activities?

  • Are the processes harmonized across all regions?

  • Do all teams speak common language when it comes to data, nomenclature and documentation?


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