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    Practice

    Mergers & Acquisitions in Regulated Industries

    BiggsB supports acquirers, investors and sellers in regulated industries with regulatory, quality, operational and technology diligence, transaction risk assessment, integration planning and post-close execution.

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    The client situation

    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.

    Who this is for

    • 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

    When clients call us

    • 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

    Scope

    • 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

    Deliverables

    • 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

    How the work is organized

    1. Stage 1

      Pre-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. Stage 2

      Diligence

      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. Stage 3

      Integration 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

    Engagement approach

    1. Step 1

      Scope

      Agree the questions that affect value, terms or timelines, and the time available.

    2. Step 2

      Evidence

      Review documentation, systems and interviews; state clearly what could not be verified.

    3. Step 3

      Advise

      Rank findings by consequence and translate them into remediation assumptions.

    4. Step 4

      Integrate

      Carry priorities into an integration plan and support post-close execution.

    Service boundaries. 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.

    Responsible expertise

    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.

    Questions about Mergers & Acquisitions

    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.

    Speak with an advisor about Mergers & Acquisitions

    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.