A healthier compliance prognosis

How a life sciences leader harnessed digital to drive compliance and boost growth

Compliance

Industry

Life sciences

Services

Artificial intelligence

Enterprise risk and compliance

Who we worked with

A leading life sciences company

What the company needed

Successful drug development depends on satisfying the regulatory requirements of drug licensing authorities—but this company had so many products that managing compliance and regulatory processes was overwhelming. Leaders couldn't easily view complete regulatory and compliance information, as local markets and global operations operated in silos. And the company's regulatory policies and processes related to chemistry, manufacturing, and controls (CMC) didn't have what it needed to support sustainable compliance, so getting new products to market was a slow process.

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 new, streamlined, highly visible compliance process means company leaders can immediately see compliance reports and information across more than 1,300 consumer health product licenses and 40 manufacturing sites around the world. The program dashboard integrates data from across all locations to provide a single version of standardized, specific reporting for each product. Real-time reporting — combined with more efficient processes — has reduced cycle and wait times, while the sustainable compliance process strategically positions the company for rapid 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, technological evolution, 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.

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 non-compliance findings during health authority inspections, and minimized the possibility of costly damage to the company's reputation.