How Outsourcing Helps Manage Regulatory Affairs in Pharma
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How Outsourcing Helps Manage Regulatory Affairs in Pharma

Stacey Smith, Pharma Tech Outlook | Wednesday, December 16, 2020

Pharma companies are increasingly seeking and relying on partnerships with contract organizations to effectively manage regulatory affairs.

FREMONT, CA: Outsourcing is common within the pharmaceutical and medical device industries, particularly within the regulatory affairs, pharmacovigilance, and medical information functions. Regulatory affairs outsourcing is also very common, with many firms seeking expert support and partnership for new products and the effective management of operational tasks. In an evolving marketing environment driven by mergers, acquisitions, globalization, and optimization blended with the race for new innovation amidst shifting regulations, increasing requirements are being placed on research and development. Read on to know more.

Companies large and small involved with outsourcing partners in different ways, for a variety of tasks ranging from simple to complex projects. Both technical and strategic outsourcing provides companies different benefits and motives to pursue. Technical outsourcing is often carried out on a project-by-project basis and is a short-term arrangement. It enables companies to manage workload, enabling them to address short-term capacity constraints. Strategic outsourcing allows for flexible internal resourcing, thus offering opportunitop pharmacovigilance companiesties for firms to identify and focus on their core strengths and long term objectives with a lean cost base. It is a competency-based model that allows companies to readily choose the most suitable outsourcing partner with the quality of skill-sets they need that they may not have internally.

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The success of outsourcing, and the realization of the opportunities it offers, therefore, lies in who firms choose to outsource to and how. In selecting an appropriate outsourcing partner, companies should seek reliable partners with technical and strategic potential and relevant expertise combined with robust internal procedures to effectively handle projects. Tailoring an outsourcing model and process between a company and its outsourcing partner is vital to success.

Outsourcing regulatory affairs, whether technical or strategic, is an evolving trend in the industry. Allowing firms to focus on their strategic imperatives, outsourcing continues to emerge and expand. While there are several opportunities for both companies and outsourcing partners to succeed, there are issues associated. A well-defined outsourcing model is key to help overcome the challenges and realize the full potential of the benefits outsourcing can bring.

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