Regulatory CMC full service outsourcing solution with a top 5 pharma

Case Study

Creating an outsourcing solution2018-06-26T13:37:08+00:00

Project Description

The challenge

As part of corporate objectives, our client needed to expand capacity for a broadening portfolio of products while reducing internal headcount and costs.

The client required the production of submission packages to global markets, for a portfolio of marketed products across the lifecycle.

The client’s key objectives were to build long-term partnerships with organisations that could provide a full-service solution with minimal oversight. They wanted to achieve productivity and cost advantages with excellent quality and risk management.

Our approach

Kinapse has had a multi-year contract supporting the client’s global CMC/Regulatory operations across all its major business units since 2010.

We work with client team leads from strategy to delivery of the published submission.

A blended local/remote Kinapse team works remotely in the client’s databases through secure virtual private networks.

Our comprehensive expert reviews assure the quality of all submissions.

A senior Kinapse Program Manager ensures best practice program and resource management and ongoing continuous improvement activities are embedded within the solution.

The result

The average cost to the client per Kinapse resource is approximately 40% of competing North American and European resources. We’re able to achieve that thanks to our large scale, blended team located in US, Europe and India.

The submissions we have delivered quickly and with high quality. The client has regularly given us positive feedback on these submissions.

We created a collaborative partnership during set up with a combination of experienced consulting resources working with Regulatory Chemistry, Manufacturing and Controls (CMC) technical experts.

As a result, the client has received ongoing cost reduction and productivity benefits from our program, resource and risk management.

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