Mergers, Acquisitions and Divestments

We support companies navigate the complexity of global MATs with speed, precision and compliance for M&A, product divestments or restructuring

• End-to-end regulatory expertise to achieve successful approval of MATs, across regions, protecting asset value, avoiding supply disruptions and accelerating timelines.
• Develop and implement regulatory strategy for MATs in each market based on latest regulations.
• Partner with your regulatory team or CRO to manage submission strategy, dossier preparation and Health Authority engagement - ensuring compliance, minimising delays, and reducing administrative burden across multiple markets.
• Prepare regulatory documents.
• Respond to Health Authorities queries.
• Plan and execute submission of MAT-linked variations, such as manufacturing sites transfers and changes in artworks, product names or local representatives.
• Regulatory point-of-contact for cross-functional teams: supply-chain, artwork, manufacturing site, comercial, business development.
• Write internal processes and SOPs to implement internally and act as regulatory subject-matter expert for Health Authority audits.

We provide specialised regulatory intelligence to support efficient, compliant MATs or product packaging switch across global markets

• Anticipate local requirements, streamline timelines and avoid delays or supply disruptions.
• Implement regulatory strategy based on market regulations for MATs and variations to minimize number of changes, ensuring compliance.
• Implement regulatory strategy for critical variations.
• Together with cross-functional teams, develop strategy to switch product packaging based on regulatory implementation timelines and selling restrictions.

We offer expert project management tailored to the complexity of MATs. From cross-functional coordination to timeline tracking and risk mitigation, we ensure every stakeholder, task, and regulatory milestone stays aligned. 

• Communication plan with regulatory and cross-functional teams.
• Act as the global regulatory point-of-contact.
• Due Diligence.
• Oversight of product data transfers between buyer and seller.
• Support with distributor transfers.
• Develop training materials and provide training to regulatory teams.
• Prepare processes and systems for M&A and divestment projects.