Case Study

A shot in the arm

Global pharma company changes its prescription for regulatory affairs operations and sees huge improvements

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Who we worked with

A global pharmaceutical company.

What the company needed

A scalable and flexible operating model for the regulatory affairs (RA) function was critical for the company to meet requirements that were highly demanding and frequently changing.

How we helped

We became a strategic partner to manage RA requirements throughout the lifecycle of mature products. That includes preparing ancillary documents, renewing licenses, authoring reports, working across therapies and business divisions, and providing support across the global operation.

What the company got

As a result of our partnership, the pharmaceutical company cut costs by 30% and is able to focus its strategic resources on value-added activities. In addition to lower costs, the partnership has boosted efficiency, streamlined maintenance processes, and improved process management across global operations.

Challenge

Create a streamlined system

Increasing compliance activities and changing global regulatory requirements posed constant challenges for the client, a leading pharmaceutical company. The company was using vendors and contractors spread across multiple countries to manage regulatory requirements, which made scalability difficult. The company often resorted to short-term and expensive arrangements to augment its talent pool and resource workload during peak times.

In addition, the company’s resources were stretched thin by a large volume of routine regulatory lifecycle management activities, leaving little time to capitalize on emerging market expansion opportunities or other high-value projects. The company needed an integrated approach that would allow its RA function to be sufficiently agile and scalable to speed up the introduction of new products.

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Solution

Partner for progress

Genpact took the regulatory maintenance burden off the client’s staff, freeing up their resources to focus on new market opportunities and getting new drugs to market quickly. Our global network of qualified regulatory professionals took over administrative tasks such as renewing licenses, authoring reports, submitting new challenge product submissions to emerging markets, and responding to health authority questions.

But our partnership isn’t just clerical. We also established an automated system to manage the client’s multitude of requests for product data from manufacturing sites across the globe. We created shared service centers to manage high-volume information and documentation requests by consolidating the workloads of in-house teams in 100 countries, standardizing those projects, and allocating them to hubs in lower-cost locations. We also defined procedures and metrics to make compliance control transparent and complexity easier to manage.

Impact

Making a difference with lower costs

With our advanced operating model in place, our client reports a 30% reduction in costs. Along with saving money, the company has accomplished an agile, responsive, sustainable, and scalable lifecycle management operations for regulatory affairs.

Compliance is improved across 100 countries, and our client is able to use its internal resources for high-value commercial priorities. Client processes include greater efficiency and standardization, which allows the company to boost drug discovery efforts and focus on its core business of improving health outcomes.

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