Mergers & Acquisitions (M&A)

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Summary:  Specialized guidance through regulatory due diligence, QMS/SOP integration planning and execution, post-merger compliance, risk assessment, and global regulatory strategy alignment.

Mergers and acquisitions in the pharmaceutical, biologic, and medical device industries involve complex regulatory considerations that can significantly impact deal success. Regal Intel offers specialized consulting services to guide you through the regulatory due diligence, integration planning, and post-merger compliance, ensuring a smooth and efficient transition.

• We conduct thorough regulatory due diligence to identify potential compliance risks and liabilities.
• Our experts assess the target company's regulatory history, compliance status, and product registrations.
• We evaluate the impact of regulatory changes and future requirements on the deal.
• We analyze eCTD submissions, and other regulatory documents.
• We analyze the target companies QMS.

• We develop comprehensive integration plans to harmonize quality management systems, regulatory processes, and compliance programs.
• Our team assists in the transfer of product registrations, licenses, and approvals.
• We ensure seamless integration of regulatory data and documentation.
• We assist with the integration of SOPs, and other QMS documents.

• We provide ongoing support to ensure continued compliance with regulatory requirements post-merger.
• Our experts assist in updating regulatory submissions and documentation to reflect the new entity.
• We conduct post-merger audits to assess compliance and identify areas for improvement.
• We will assist with any post merger regulatory agency meetings.

• We evaluate the risks associated with the merger or acquisition, and create mitigation plans.
• We analyze the risks associated with the QMS integration.
• We analyze the risks associated with product registrations.

We will assist in the alignment of global regulatory strategies, so that the new company has a cohesive global regulatory plan.

• Specialized Expertise: Our team possesses in-depth knowledge of regulatory requirements and M&A processes.
• Thorough Due Diligence: We conduct comprehensive assessments to identify potential risks and liabilities.
• Seamless Integration: We develop and execute integration plans to minimize disruptions and ensure compliance.
• Ongoing Support: We provide post-merger support to ensure continued compliance and success.