A healthier compliance prognosis

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

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.

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.