A plan with advisory services, a sharp new tool, and an integration mindset
Our M&A consultancy has well-tested techniques to tackle these roadblocks to growth. We guide companies right from the earliest stages of their M&A, all the way through ongoing submissions, reporting, and compliance maintenance.
Here's how we help. We take a cross-functional approach that combines regulatory affairs, manufacturing, and data quality into a single entity. This smart, interconnected system helps you avoid repeat submissions, manage supply chain changes such as product releases aligned with regulatory timelines, and ensure that regulators are getting the detailed information they need for approvals. And the robust governance process we devise with you tracks and effectively manages the merger. You get a clear line of sight and full transparency from the first integration steps until the moment an updated product enters the market.
Our work encompasses three phases. Phase one entails fact-gathering to assess the impact of the M&A. Then, we go to work planning. We determine the status of licenses, clinical trial applications, and SKUs, outlining actions such as transfers or other changes that each will need. This helps us set priorities, such as getting products that are medically necessary to market quickly, while keeping revenue goals in mind. Next, we establish a budget estimate for managing integration. Finally, we work with people in regulatory, manufacturing, and quality functions to draw up global, regional, and local governance forums.
In the next phase, we act on what we've learned. While we develop and refine submission plans and provide help updating paperwork, we work with people in regulatory, supply, and quality to set timetables for applications, reports, and products. MAST, our marketing authorization supply transfer solution, which integrates planning and implementation across the regulatory and supply functions, makes that job easier. This secure, cloud-based analytical tool with built-in regulatory intelligence as an accelerator captures critical cross-functional milestones and links marketing applications with supply SKUs. It generates an integrated view on its dashboard and can even simulate future scenarios, identify gaps associated with the distribution of products, and track workloads in the finest detail. It provides an end-to-end integrated view across regulatory, safety, and quality and prevents revenue loss (see figure 1).
Meanwhile, we conduct forums on governance to ensure that your company is managing risks and issues proactively and keeping close track of all reports.
Phase three is the maintenance stage. We connect with all distributors and national representatives to keep compliance requirements and submissions up to date. At the same time, we monitor the migration of data to make sure it is clean, centralized, and harmonized in go-forward systems.