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    BiggsB Global · 30 years in regulated industries

    Global regulatory, M&A and AI advisory.

    For 30 years, BiggsB has supported organizations operating in regulated industries. Our experience includes global project management engagements for Roche, Pfizer and GSK. We combine global regulatory advisory with program delivery, validation and preclinical expertise, and support clients with mergers and acquisitions and AI regulation and governance.

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    Practices
    Global regulatory · Mergers & acquisitions · AI regulation & governance
    Industries
    Life Sciences · Healthcare · Regulated Technology
    Engagements
    Advice and the execution that follows, led by senior practitioners

    Selected pharmaceutical experience

    BiggsB has delivered global project management engagements for Roche, Pfizer and GSK.

    Global Program & Project Management

    Expertise

    Three primary practices

    1. 01

      Global Regulatory Advisory

      BiggsB advises organizations on regulatory strategy across markets and carries out the work that follows: market-entry planning, submission support, regulatory intelligence, lifecycle obligations and remediation, coordinated across the jurisdictions in which a product or business operates.

      • Regulatory strategy and market-entry planning across target markets
      • Submission planning, preparation support and review
      • Regulatory intelligence: monitoring changes and assessing their impact
      • Lifecycle obligations: post-market requirements, changes and renewals
      Global Regulatory practice
    2. 02

      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.

      • 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
      Mergers & Acquisitions practice
    3. 03

      AI Regulation & Governance

      BiggsB helps regulated organizations determine which AI rules apply, assess and govern AI risk, and assure the AI-enabled systems they build or buy, with clear human accountability and ongoing monitoring.

      • Regulatory applicability: which AI rules apply and in what role
      • AI use-case inventory and risk assessment
      • Governance: policy, roles, decision rights and accountability
      • Model and system assurance: validation of AI-enabled systems
      AI Regulation & Governance practice

    Supporting capabilities

    Program delivery, validation and preclinical expertise that carry advice into execution, alongside quality, Veeva, leadership and diligence specialists.

    Industries

    Industries and regulatory frameworks

    Industries we serve

    • Life Sciences

      Pharmaceutical, biotech, medical device and diagnostics companies, and the clinical research organizations that support them, from development through submission, manufacturing and post-market obligations.

    • Healthcare

      Healthcare organizations that handle patient data and adopt AI and digital services under privacy, security and clinical governance obligations.

    • Regulated Technology

      Technology companies whose products are used in regulated settings, or are regulated themselves, and that must show customers, auditors and investors how their systems and AI are controlled.

    Frameworks we work with

    • United States — FDA and HHS frameworksIND and NDA support; 21 CFR Part 11; HIPAA
    • European Union — EMA and EU frameworksCTA and MAA support; EU GMP Annex 11; EU AI Act; GDPR
    • International standards and guidanceICH guidelines; GAMP 5 and computer software assurance principles; ISO/IEC 42001 and NIST AI RMF for AI governance

    These describe service coverage, not office locations.

    BiggsB Ventures

    BiggsB Ventures Accelerator

    BiggsB Ventures is a structured accelerator for founders building in regulated industries. It applies BiggsB's regulatory, quality and operating experience to early-stage companies so that product, regulatory path and commercial plan develop together.

    Express Interest

    Enabling technology

    Our practitioners use regulatory technology to research and document faster: DAIN regulatory assistant, rEGS knowledge graph, RegForge. People remain accountable for the advice. How we use AI.

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