Client: A leading pharmaceutical company, ranked among the top ten globally
Industry: Life sciences
Business need addressed:
- Lack of visibility into existing compliance and regulatory processes and data
- Fragmented view of regulatory and compliance information being shared from local markets to global operations
- CMC regulatory policies and processes unable to support sustainable compliance
- Transformed governance and compliance operating model enabled by flexible resource support
- Targeted technology interventions such as a real-time program dashboard for project reporting and insight
- A sustainable compliance, positioning the company for rapid growth
- Improved visibility and reporting across more than 1,300 consumer health product licenses and 40 manufacturing sites globally
- “Single version of truth" data and technology integration enabling standardized and market specific reporting for each product, which improved chemistry, manufacturing and controls (CMC) process efficiency while reducing cycle times and wait times
The ability to effectively manage risk and compliance is critical in the life sciences industry, where organizations face a wide range of risks driven by regulatory and market-driven pressures. One of the world's foremost life sciences companies had poor visibility into existing compliance processes and related data. By transforming their CMC operating model through a combination of Lean principles, flexible resource support, targeted technology interventions and domain knowledge, this life sciences leader minimized compliance risks and reduced costs, while ensuring a future-proof platform for growth.
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 national or legacy formats (e.g. ICH-CTD*).
Further, disparate technology and data capture systems hindered “one single version of truth" data, which resulted in a fragmented view of regulatory and compliance information being shared from local markets to global operations, putting the organization at risk of being non-compliant.
The regulatory affairs function pursued an end-to-end compliance initiative while ensuring minimum disruption to “business as usual" in a cost-effective and scalable way. An “as-is" state assessment revealed the urgent need for transforming the company's governance and compliance framework to increase standardization, implement system-driven processes and enable future readiness through a combination of Lean principles and domain expertise. To ensure sustainable compliance, this company transformed its operating model with Genpact Pharmalink's flexible resource support to accommodate peaks and troughs of workload during the compliance initiative. This included a dedicated team of compliance specialists and use of the Pharmalink Affiliate Network of regulatory affairs consultants to collect locally registered CMC data from the regulatory affiliate locations to address client resource constraints. Targeted technology interventions and knowledge support helped improve project reporting to stakeholders through tools such as real-time project information dashboards.
The implementation of a best-in-class CMC compliance system helped the client ensure sustained compliance, and supported the organization to focus on transformation opportunities across the value chain to generate greater patient and business value. The improved visibility and reporting across over 1,300 consumer health product licenses and 40 manufacturing sites helped in the setting up of better global compliance controls. This reduced the risk of non-compliance findings during health authority inspections, and minimized damage to company reputation and related costs. The “single version of truth" data and technology integration enabled standardized and market-specific reporting for each product, clarifying what is actually registered in each market. This improved CMC process efficiency, reduced cycle and wait times for CMC processes, and improved “first time right" throughput.
*ICH-CTD: International Council for Harmonisation - Common Technical Document