In the fast-evolving medical device industry, mergers and acquisitions are key strategies for growth and expansion. However, each market has its unique regulatory landscape and understanding these requirements is crucial for a successful transaction.
The collective expertise of Emergo by UL professionals around the globe prepares you to navigate regulatory complexities across multiple jurisdictions, minimizing risks and supporting compliance. Our regulatory M&A analysis service helps companies plan for seamless product license updates and transfers, maintaining market access and avoiding costly disruptions.
ANSWERED ON THIS PAGE:
- What is the benefit of Emergo’s regulatory M&A analysis services?
- What does the regulatory M&A analysis service include?
- When should companies consider the regulatory M&A analysis service?
Emergo by UL regulatory analysis for M&A services
Emergo will analyze the regulatory impact of the envisaged merger or acquisition and outline a regulatory roadmap for each country or market for prioritization. The goal is to develop a regulatory overview that allows for planning product registration and license transfers without disrupting market access, facilitating business continuity, revenue growth and helping your management realize the expected benefits of M&A activities.
Emergo’s regulatory analysis for M&A companies also includes:
Regulatory requirements
Determine if formal notifications to health authorities are needed and whether re-registration or registration modification updates are required
Timelines
Provide detailed timelines for the regulatory change process, including key milestones and deadlines.
Government fees
Outline applicable government fees associated with regulatory changes
Sell-off provisions
Identify any sell-off provisions for remaining inventory
Impact assessment
Evaluate the impact on the validity/expiration date of registration licenses and product labeling
Stakeholder responsibilities
Define the roles and responsibilities of key stakeholders, including the legal manufacturer, local representatives, importers and distributors
Emergo’s M&A regulatory analysis service is administered in the following stages:
Pre-acquisition regulatory analysis
Our pre-regulatory M&A analysis service includes:
Quality management system (QMS) Evaluation
Assessing the target company’s quality management system (QMS)
Regulatory documentation review
Analyzing regulatory status
Risk identification
Identifying potential regulatory risks and liabilities
Impact Assessment
Assessing the impact of upcoming regulatory changes
Post-acquisition regulatory acquisition
Our post-regulatory M&A analysis service includes:
Regulatory strategy development
- Creating a unified regulatory strategy
- Leveraging existing approvals and registrations
Regulatory submissions and registrations
- Preparing and submitting regulatory applications
- Supporting compliance with local requirements
- QMS integration: Conducting gap analyses and harmonizing QMS processes
- Implementing a unified QMS
Post-market surveillance and vigilance
- Establishing post-market surveillance processes
- Supporting compliance with adverse event reporting
Ongoing regulatory support
Our ongoing M&A analysis service includes:
Regulatory intelligence and monitoring
Keeping up with global regulatory changes
Product lifecycle management
Assisting with regulatory maintenance activities
Representation and advocacy
Representing your company with regulatory authorities
Training and education
Providing training for regulatory affairs and quality management teams
When is Emergo’s regulatory M&A analysis relevant?
This service is highly relevant for companies planning mergers or acquisitions, especially those involving a higher volume of different global markets. Companies in the following scenarios benefit from Emergo’s M&A analysis services:
Mergers with foreign companies
Companies merging with foreign entities need to understand the regulatory requirements and stakeholder roles in various global markets
Acquisitions of overseas companies
Companies acquiring international organizations must navigate different regulatory landscapes to achieve compliance and market access
Complex regulatory environments
Organizations operating in markets with complex regulatory environments like Japan or China benefit from a regulatory analysis to avoid disruptions
Strategic growth
Companies looking to expand their product portfolios and market reach through M&A activities need to plan for seamless regulatory transitions
Common questions about Emergo’s regulatory M&A analysis services
Why is the regulatory analysis service important for medical device companies during M&A?
Emergo’s regulatory M&A analysis service helps companies understand the regulatory landscape, supporting product license transfers to be planned without disrupting market access to facilitate business continuity and revenue growth.
Emergo provides a detailed roadmap of regulatory requirements, timelines and stakeholder responsibilities, helping companies navigate complex regulatory changes smoothly and efficiently during M&A transactions.
How does Emergo provide quality and accuracy during our M&A regulatory analysis service?
With over 25 years of experience and a global presence in more than 20 markets, Emergo’s team of experts leverages deep regulatory knowledge to deliver accurate and actionable insights tailored to your specific M&A needs.
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