- Case study
A healthier compliance prognosis
How a life sciences leader harnessed digital to drive compliance and boost growth
Who we worked with
One of the world’s leading pharmaceutical companies, with operations in over a 100 countries.
What the company needed
Better visibility into regulatory compliance processes. Transformed regulatory policies and processes related to chemistry, manufacturing, and controls (CMC) to ensure sustainable compliance. Improved speed to market for new products.
How we helped
We harnessed flexible resource support to transform the company’s governance and compliance operating model. That included implementing targeted technology interventions such as a real-time program dashboard for project reporting and insights.
What the company got
A compliance process that improves visibility into regulatory operations for over 1,300 consumer health product licenses and 40 manufacturing locations. The program dashboard integrates regulatory data across locations to enable real-time reporting. When combined with the transformed processes, this helps improve process efficiency and reduce cycle times - While the sustainable compliance process positions the company for growth.
Challenge
Get a grip on compliance
Companies have to prepare for a wide range of risks as they adapt their businesses to changing regulatory and market-driven pressures, such as market expansion, new technology, and evolving stakeholder expectations.
This global leader lacked visibility into existing compliance and regulatory processes and data. The registered information related to products was stored in multiple formats across markets globally, and product dossiers were often in local or legacy formats. In addition, disparate technology and data-capture systems resulted in a fragmented view of regulatory and compliance information that was shared from local markets to global operations, putting the organization at risk of being non-compliant
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Solution
Build a better view
Genpact provided flexible resource support to help the company transform its operating model, developing an end-to-end compliance initiative without disrupting business as usual. We assessed the current operations and found an urgent need to transform the company’s governance and compliance framework: It needed to be standardized, with system-driven processes and future readiness.
We deployed a dedicated team of compliance specialists and regulatory affairs consultants to address the client’s resource constraints. We also implemented targeted technology interventions and knowledge support to improve project reporting to stakeholders through tools such as a real-time project information dashboard.
Impact
A future-ready company
By implementing a best-in-class CMC compliance system, the company can not only sustain compliance, it can generate greater patient and business value by focusing on transformation opportunities across the value chain. The CMC process is faster and more efficient, so processes are completed right the first time and cycle and wait times are reduced.
With improved visibility and reporting across more than 1,300 consumer health product licenses and 40 manufacturing sites, the company has better global compliance controls. This reduced the risk of noncompliance findings during health authority inspections, and minimized the possibility of costly damage to the company’s reputation.
See how we help life sciences firms transform regulatory affairs
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