Mergers & Acquisitions in Regulated Industries

A transaction depends on whether a target's authorizations, quality system and regulated systems will support the investment case. Deal teams need evidenced findings, ranked by consequence, in time to shape terms and integration.

• -Corporate acquirers evaluating regulated targets
• -Private equity and venture investors in life sciences, healthcare and regulated technology
• -Sellers preparing a regulated business for sale
• -Integration leaders responsible for regulated operations after close

• -A transaction is entering diligence and regulatory risk is unclear
• -A seller wants an independent view of readiness before a process
• -Deal terms depend on remediation assumptions
• -A deal has closed and quality systems, computerized systems and authorizations must be integrated

• -Buy-side and sell-side regulatory and quality diligence
• -Operational and technology diligence, including validation status and data integrity
• -Transaction risk assessment and remediation assumptions
• -Integration planning for regulated operations, quality systems and computerized systems
• -Post-close execution: quality system integration, remediation and change control

• -Diligence findings with risk ratings and evidence references
• -Priority risk summary for decision makers
• -Remediation assumptions with effort estimates
• -Integration plan for regulated operations and systems

1. 01Pre-transaction assessment. Agree the regulatory and quality questions that matter to the investment case, review available information and identify early red flags. Deliverables: Diligence scope and question list; Initial red-flag summary.
2. 02Diligence. Test records, systems and interviews against the questions: authorizations, inspection history, quality system maturity, data integrity, pipeline assumptions and technology. Deliverables: Diligence findings report; Priority risks and remediation assumptions; Inputs for deal terms.
3. 03Integration and post-close execution. Plan and carry out integration of quality systems, regulated systems and regulatory responsibilities without disrupting supply or commitments. Deliverables: Integration plan; Day-one continuity checklist; Integration progress reporting.

1. 01Scope. Agree the questions that affect value, terms or timelines, and the time available.
2. 02Evidence. Review documentation, systems and interviews; state clearly what could not be verified.
3. 03Advise. Rank findings by consequence and translate them into remediation assumptions.
4. 04Integrate. Carry priorities into an integration plan and support post-close execution.

Each engagement is led by a senior BiggsB practitioner with experience of the relevant regulatory framework, supported by specialists from the supporting capabilities as the scope requires.

BiggsB provides regulatory, quality, operational and technology diligence and integration support. We do not provide investment banking, legal representation, financial audit or valuation services; our work complements legal and financial diligence.

Do you support buy-side and sell-side work?

Yes. Buy-side work tests a target's regulatory and quality position; sell-side work gives a seller an independent view of readiness before a process.

How do we share confidential transaction information?

Start with a high-level description only. If there is a fit, we agree a non-disclosure agreement and arrange a confidential discussion before any detailed information is shared.

What happens after close?

We can carry diligence priorities into an integration plan and support execution: quality system integration, remediation and change control for regulated systems.

• Regulatory & Technology Due Diligence — due-diligence
• Global Program & Project Management — global-program-management
• Computer System Validation & Computer Software Assurance — compliance-validation

Use the inquiry form, email connect@biggsb.com, or book a call. For transaction work, describe the situation at a high level only: the type of target, your role (buyer, seller or investor) and the timeline. Do not include confidential deal information in the form. If there is a fit, we will arrange a confidential discussion and agree a non-disclosure agreement before any detailed information is shared.

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