A global pharmaceutical company
Business need addressed:
- Create a scalable and flexible operating model for the Regulatory Affairs (RA) function to meet fluctuating, and highly demanding regulatory resource requirements
- Streamline vendor management and identify cost efficiencies
- Improve compliance with global regulatory requirements
- Capitalize on emerging market expansion opportunities
- Supported operating model evolution by providing sustainable outsourcing of RA requirements for lifecycle management of mature products
- Evolved client service model to a strategic partnership
- Decoupled processes and operationalized low-risk activities, such as ancillary document preparation, license renewals, annual reports, and authoring
- Consolidated divisional support into global shared-service hubs, working across therapies and business divisions
- Delivered 30% cost savings
- Released client’s strategic resources to focus on value-added activities
- Generated efficiency gains in lifecycle management processes, including Chemistry, Manufacturing and Controls (CMC) document authoring, license renewals, and ancillary document processes
- Streamlined maintenance processes and improved process management across global operations
Under financial pressures to achieve new growth and reduce costs, pharmaceutical companies are looking to the regulatory and safety functions to demonstrate their value and achieve more with less. Speed to market, managing regulatory complexity, and ability to maintain compliance are critical to retaining market share. Best-in-class pharmaceutical leaders have evolved operating models and organizational structures to refocus business operations, streamline processes, and cut costs.
The client, a leading pharmaceutical company, was looking to identify an integrated approach to manage the challenges posed by increasing compliance activities and global regulatory requirements. Its RA function needed to be agile and scalable to speed up the introduction of new products; its existing resource mix, however, included vendors and contractors spread over different countries, which made scalability difficult. The client, therefore, often resorted to short- term and expensive arrangements to augment its talent pool and resource workload during peaks. Furthermore, its highly skilled CMC resources were stretched thin by a large volume of routine regulatory lifecycle management activities, leaving little time for high-value commercial projects.
Genpact Pharmalink had been providing regulatory services to the client for a number of years. Over time, with increased client confidence in vendor performance and provision of high-quality support, service scope expanded to include project partnerships, with Genpact Pharmalink managing more complex projects, evolving into a strategic partner, and providing sustainable outsourcing for various activities in RA.
The client’s operating model was redesigned to better meet business needs, with Genpact Pharmalink acting as a strategic partner providing access to a global network of qualified regulatory professionals and expertise in transforming complex operations through consolidation, standardization and continuous improvement. This began with Genpact Pharmalink taking over the administrative tasks in the CMC section of license renewals; then, building on experience and product knowledge, the remit expanded to authoring Common Technical Document (CTD) dossier sections for license renewals. Task by task, the scope grew into performing all CMC requirements for license renewals, and continued expanding until 2014 when a dedicated Genpact Pharmalink organization managed all CMC requirements and provided submissions and publishing support across multiple activities in lifecycle management. In addition to license renewals this included:
- New product submissions to emerging markets, including authoring CMC, compiling regional and ancillary documents, and responding to Health Authority (HA) questions
- Line extensions and variations
Employing a mix of on-, near- and off-shore resources allowed for efficiency and scalability as global compliance demands increased. In this way, the client not only benefits from Genpact Pharmalink’s dedicated team but also leverages a variable resource and cost model to address spikes, and can requisition additional technical staff for projects and tasks, as needed.
The advanced operating model transformed critical aspects of the client’s RA function by:
- Process standardization and re-design for global delivery
Decouple and operationalize processes: To manage the huge number of license renewal submissions, a new standard global process was set up. Lower risk activities were decoupled and delivered from cost-effective near- and off-shore service centers. A follow-the-sun support model ensured faster turnaround times.
Dedicated teams for emerging market submissions: A Genpact Pharmalink team embedded within the client’s team helped enhance overall product knowledge, history, and awareness. The team focused on submissions for multiple products, reducing time to file in these markets.
Establish robust compliance controls: Well-defined procedures and metrics made compliance control transparent and complexity easier to manage.
- Technology tranformation to drive consolidation and automation
An automated system helped consolidate the multitude of requests for similar data for each product sent to manufacturing sites across the globe to a minimum number of bolus requests. Requests were also consolidated and harmonized across 100 countries through a single system with a defined dictionary of available documentation.
- Setting up shared service centers for global delivery
Workload and assignments from in-house teams in 100 countries were systematically disaggregated, industrialized, standardized, and then allocated to hubs in lower-cost locations. These shared services centers managed high-volume information and documentation requests.
The advanced operating models resulted in agile, responsive, sustainable, and scalable lifecycle management operations for regulatory affairs, managing planned and unplanned activities and improving compliance across 100 countries. This enabled the client to effectively use its internal resources for high-value commercial priorities. Greater efficiency and standardization were instilled in client processes, which, in combination with off-shore service consolidation, helped drive an approximately 30% reduction in cost.
Genpact Pharmalink is the global regulatory affairs organization of Genpact.
For more information, contact, email@example.com and visit, genpact.com/what-we-do/industries/regulatory-affairs