Regulatory M&A services are critical for medical device companies
The medical device industry is undergoing rapid growth and transformation, driven by technological advancements, evolving healthcare needs, and global market expansion. Mergers and acquisitions (M&A) have become a strategic tool for companies to enhance their capabilities, expand their product portfolios, and enter new markets. Navigating the complexities of M&A in the medical device industry requires specialized regulatory expertise. Emergo by UL offers various regulatory M&A services designed to support compliance, streamline processes and facilitate smooth transitions to help prevent business disruptions.
Emergo by UL provides specialized Regulatory M&A services to address these challenges, leveraging over 25 years of industry experience and a global presence in over 20 markets. Our expertise helps ensure that regulatory compliance is seamlessly integrated into your M&A strategy, facilitating smooth transitions, and helping to preserve the value of your transactions.
How we can help medical manufacturers with M&A service offerings
Our M&A services are structured across three key phases to provide customized support at every stage of the merger or acquisition:
Pre-M&A Phase
Regulatory M&A analysis
Our professionals will identify regulatory requirements and key stakeholders in each market. They will assess whether formal notifications/submissions are needed, determine whether re-registration or registration modifications are required and outline timelines, government fees and impacts on labeling and license validity.
RA/QA due diligence support
Regulatory Affairs/ Quality Assurance (RA/QA) will assess current compliance status and identify areas for improvement in the quality management system (QMS), including reviewing existing regulatory documentation, identifying non-compliant areas and providing remediation recommendations.
M&A regulatory strategy
Develop a strategic plan for navigating regulatory requirements, prioritizing actions and mitigating risks. Our managers will create a detailed roadmap for compliance, helping to prioritize devices and markets based on strategic importance. And assess potential regulatory risks and develop mitigation strategies.
Transition Phase
Dossier compilation and remediation support
Address regulatory gaps in technical documentation and prepare comprehensive regulatory dossiers for product approval. Our professionals will update and compile the necessary regulatory documentation.
Registration transfer support
Manage the technical and administrative aspects of transferring product registrations seamlessly. We submit all required documentation and coordinate with regulatory authorities.
Post-M&A Phase
In-country representation services
Helping to maintain regulatory compliance and market access during the transitional period post-M&A. Our professionals provide interim authorized representation in key markets.
Post-M&A regulatory integration support
Integrate QMS and regulatory processes to support ongoing compliance and operational continuity. Our specialists develop and help implement a compliance plan and harmonize QMS and regulatory processes.
Common questions about regulatory M&A services
What role do regulatory requirements play in mergers and acquisitions for medical device companies?
Regulatory requirements help to enforce laws mandating that medical devices meet safety, efficacy and quality standards set by regulatory authorities across different markets. During mergers and acquisitions, it is crucial to adhere to regulatory requirements to maintain market access. Compliance with these requirements facilitates the continued market access that allows the merged or acquired products to continue to be sold without interruption, thereby helping to preserve revenue streams and maintaining business continuity.
How can non-compliance with regulatory requirements impact the outcome of a merger or acquisition?
Non-compliance with regulatory requirements can significantly impact the success of a merger or acquisition. It can lead to delays in product registrations, recalls, or market withdrawals, which can disrupt business operations and result in financial losses. Additionally, regulatory authorities may impose fines or sanctions, damaging the company's reputation. These risks underscore the importance of integrating regulatory planning into the M&A process to support a smooth transition and maintain business continuity.
X
Emergo can help support compliance and market access during and after a merger or acquisition
Contact us to request more information from our specialists.
Please wait…