{
  "schemaVersion": "1.0",
  "kind": "biggsb.company",
  "name": "BiggsB Global",
  "alternateName": "BiggsB",
  "url": "https://biggsb.com/",
  "canonicalUrl": "https://biggsb.com/about",
  "agentViewUrl": "https://biggsb.com/agents",
  "description": "BiggsB Global is a practitioner-led consulting and execution partner for regulated organizations. Our distributed team helps life sciences, healthcare and health technology companies with regulatory consulting, AI governance, computer system validation, quality systems, clinical operations and fractional executive leadership.",
  "facts": [
    {
      "id": "what",
      "label": "What we are",
      "value": "A consulting firm that delivers hands-on regulatory, quality, validation and AI governance work, not a software vendor."
    },
    {
      "id": "who",
      "label": "Who we serve",
      "value": "Pharmaceutical, biotech, medical device, clinical research and health technology organizations, and investors assessing regulated companies."
    },
    {
      "id": "how",
      "label": "How we work",
      "value": "Remote-first and distributed, with no central office. Senior practitioners embed with your team in your time zone."
    },
    {
      "id": "technology",
      "label": "Technology",
      "value": "Our practitioners use regulatory technology including DAIN, rEGS and RegForge to work faster; people remain accountable for advice."
    }
  ],
  "sectors": [
    "Healthcare & Life Sciences",
    "Pharmaceutical & Biotech",
    "Medical Devices & Diagnostics",
    "Clinical Research & Trials",
    "Health Technology & Digital Health",
    "Information Security & Privacy",
    "AI Governance & Responsible Technology",
    "Regulatory Compliance & Quality"
  ],
  "topics": [
    "Regulatory consulting",
    "AI governance",
    "Computer system validation",
    "Computer software assurance",
    "GxP quality systems",
    "Inspection readiness",
    "Clinical operations",
    "Veeva Vault",
    "Regulatory due diligence",
    "Fractional executive leadership"
  ],
  "leadership": "BiggsB does not currently publish named practitioner or leadership biographies on this site. Ask during an initial conversation about the practitioners proposed for your engagement.",
  "services": [
    {
      "id": "regulatory-ai",
      "name": "AI Governance & Regulatory AI Consulting",
      "summary": "BiggsB helps regulated organizations put AI to work without losing control of quality, compliance or accountability. We design AI governance frameworks, assess the risk of AI-enabled systems, and bring computer system validation discipline to models and AI-assisted processes used in GxP, clinical and healthcare settings.",
      "idealClients": [
        "Life sciences and healthcare organizations introducing AI into regulated processes",
        "Health technology companies whose products or services rely on AI and serve regulated customers",
        "Quality, compliance and IT leaders asked to approve AI use without an existing policy",
        "Investors and acquirers assessing how a target governs its AI"
      ],
      "canonicalUrl": "https://biggsb.com/services/regulatory-ai"
    },
    {
      "id": "compliance-validation",
      "name": "Computer System Validation & Computer Software Assurance",
      "summary": "BiggsB plans, executes and modernizes computer system validation (CSV) for regulated organizations. We apply risk-based methods, including computer software assurance (CSA) and GAMP 5 principles, so validation effort matches system risk and the resulting evidence stands up to inspection.",
      "idealClients": [
        "Pharmaceutical, biotech and medical device companies implementing or upgrading GxP systems",
        "Software and cloud providers whose products are used in GxP environments",
        "Quality and IT teams with validation backlogs or legacy, document-heavy methods",
        "Organizations validating AI-enabled or SaaS platforms for the first time"
      ],
      "canonicalUrl": "https://biggsb.com/services/compliance-validation"
    },
    {
      "id": "gxp-clinical-operations",
      "name": "Quality Systems, GxP Operations & Inspection Readiness",
      "summary": "BiggsB builds and strengthens quality systems for GxP-regulated organizations. We help teams establish or remediate a quality management system (QMS), manage audits and corrective and preventive actions (CAPA), write workable procedures, and prepare people and evidence for regulatory inspection.",
      "idealClients": [
        "Growing life sciences companies that need a QMS that scales",
        "Organizations responding to inspection observations or audit findings",
        "Clinical and operations teams working in GxP-regulated environments",
        "Leadership teams preparing for a first or upcoming regulatory inspection"
      ],
      "canonicalUrl": "https://biggsb.com/services/gxp-clinical-operations"
    },
    {
      "id": "clinical-preclinical",
      "name": "Clinical & Pre-Clinical Support",
      "summary": "BiggsB supports drug development programs from pre-clinical work through submission and post-market obligations. We help sponsors plan and oversee studies, prepare regulatory submissions, and run clinical operations with the quality discipline regulators expect.",
      "idealClients": [
        "Emerging biotech and pharmaceutical sponsors without a full internal regulatory team",
        "Clinical operations teams that need experienced capacity",
        "Sponsors preparing an IND, CTA, NDA or MAA"
      ],
      "canonicalUrl": "https://biggsb.com/services/clinical-preclinical"
    },
    {
      "id": "veeva-ecosystem",
      "name": "Veeva Implementation & Administration",
      "summary": "BiggsB implements, configures and administers Veeva applications for life sciences organizations. We help teams get Veeva Vault and related systems working for their processes, validated appropriately, and maintainable after go-live.",
      "idealClients": [
        "Organizations implementing Veeva Vault applications",
        "Teams that need ongoing Veeva administration capacity",
        "Companies integrating Veeva with other clinical, quality or commercial systems"
      ],
      "canonicalUrl": "https://biggsb.com/services/veeva-ecosystem"
    },
    {
      "id": "fractional-leadership",
      "name": "Fractional Executive Leadership",
      "summary": "BiggsB provides embedded, part-time executive leadership for regulated organizations that need senior compliance, quality, validation or AI governance leadership without a full-time hire. Fractional leaders own strategy and outcomes while building the team and systems that will carry the function forward.",
      "idealClients": [
        "Growth-stage and PE-backed companies that need mature compliance leadership",
        "Organizations between permanent hires or building a function for the first time",
        "Companies deploying AI in healthcare, clinical research or regulated data environments"
      ],
      "canonicalUrl": "https://biggsb.com/services/fractional-leadership"
    },
    {
      "id": "due-diligence",
      "name": "Regulatory & Technology Due Diligence",
      "summary": "BiggsB helps investors and acquirers understand the regulatory, quality and technology risk in a target before they commit. We assess compliance maturity, systems and data integrity, identify issues that affect value or timelines, and provide a practical remediation roadmap.",
      "idealClients": [
        "Private equity and venture investors evaluating life sciences or health technology companies",
        "Corporate acquirers assessing regulated targets",
        "Companies preparing for investment that want an independent readiness view"
      ],
      "canonicalUrl": "https://biggsb.com/services/due-diligence"
    }
  ],
  "servicesExportUrl": "https://biggsb.com/agents/services.json",
  "regforge": {
    "relationship": "RegForge is part of the regulatory technology BiggsB practitioners use during consulting engagements, alongside DAIN and rEGS. BiggsB does not sell it as a standalone product; consultants remain accountable for all advice. RegForge itself is described at regforge.ai.",
    "pageUrl": "https://biggsb.com/regforge",
    "externalUrl": "https://regforge.ai"
  },
  "technology": [
    {
      "id": "dain",
      "name": "DAIN regulatory assistant",
      "description": "Regulatory orientation with escalation to human experts.",
      "url": "https://biggsb.com/regulatory-assistant"
    },
    {
      "id": "regs",
      "name": "rEGS knowledge graph",
      "description": "Internal regulatory knowledge graph used by BiggsB practitioners.",
      "url": "https://biggsb.com/knowyourregs"
    },
    {
      "id": "regforge",
      "name": "RegForge",
      "description": "How RegForge compliance workflows relate to BiggsB engagements.",
      "url": "https://biggsb.com/regforge"
    },
    {
      "id": "trust",
      "name": "Trust and AI use",
      "description": "How AI tools are used and where humans stay accountable.",
      "url": "https://biggsb.com/trust"
    }
  ],
  "contact": {
    "email": "connect@biggsb.com",
    "contactUrl": "https://biggsb.com/contact",
    "bookingUrl": "https://calendly.com/biggsb-global_consultation",
    "responseExpectation": "Expect a reply within one business day.",
    "routes": [
      {
        "id": "dain-intake",
        "name": "DAIN intake",
        "description": "On the contact page, describe your need to DAIN, BiggsB's AI intake assistant. It asks a few questions for the relevant service and sends the inquiry to the matching BiggsB advisor team."
      },
      {
        "id": "contact-form",
        "name": "Contact form",
        "description": "A classic contact form on the same page, for visitors who prefer not to use the intake assistant."
      },
      {
        "id": "booking",
        "name": "Book a consultation call",
        "description": "Schedule a consultation call directly through the booking page."
      },
      {
        "id": "email",
        "name": "Email",
        "description": "Write to connect@biggsb.com."
      }
    ]
  },
  "faqs": [
    {
      "question": "What does BiggsB Global do?",
      "answer": "BiggsB Global is a practitioner-led consulting and execution partner for regulated organizations. We help life sciences, healthcare and health technology teams with regulatory consulting, AI governance, computer system validation, quality systems and inspection readiness, clinical operations, Veeva, due diligence and fractional executive leadership."
    },
    {
      "question": "Which organizations are a good fit?",
      "answer": "Organizations working under FDA, EMA, GxP or similar obligations that need experienced people to deliver, not just advise: growing biotech and pharmaceutical companies, medical device and health technology firms, software providers serving GxP customers, and investors assessing regulated targets."
    },
    {
      "question": "How do BiggsB's services relate to RegForge?",
      "answer": "BiggsB is a consulting firm. RegForge is compliance workflow software with its own website at regforge.ai. BiggsB consulting engagements may use regulatory technology such as RegForge, DAIN and rEGS to work faster, but BiggsB's services are delivered and owned by our practitioners. Software questions belong with RegForge directly."
    },
    {
      "question": "How does BiggsB work with clients?",
      "answer": "We work as a distributed team with no central office, embedding with your people in your time zone. Senior practitioners stay engaged throughout, and every engagement ends with a handover your team can maintain."
    },
    {
      "question": "How can a prospective client start a conversation?",
      "answer": "Use the Discuss Your Project page to describe your situation to DAIN, our intake assistant, or use the standard contact form. You can also book a call directly. A member of the team reviews every inquiry."
    }
  ],
  "resources": [
    {
      "id": "blog",
      "name": "Blog",
      "description": "Regulatory news and analysis.",
      "url": "https://biggsb.com/blog"
    },
    {
      "id": "guides",
      "name": "Guides and resources",
      "description": "Practical regulatory resources.",
      "url": "https://biggsb.com/insights"
    },
    {
      "id": "how-it-works",
      "name": "How DAIN requests work",
      "description": "How AI-assisted requests are reviewed by experts.",
      "url": "https://biggsb.com/how-it-works"
    },
    {
      "id": "trust",
      "name": "Trust and AI use",
      "description": "How AI tools are used and where humans stay accountable.",
      "url": "https://biggsb.com/trust"
    }
  ],
  "recentArticles": [
    {
      "title": "Biotech Regulatory Shifts: Navigating the 2026 Landscape with BiggsB Global",
      "url": "https://biggsb.com/blog/2026-02-05-biotech-regulatory-shifts-navigating-the-2026-landscape-with-biggsb-global",
      "published": "2026-02-05",
      "updated": "2026-02-05"
    },
    {
      "title": "Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026",
      "url": "https://biggsb.com/blog/2026-02-04-navigating-510-k-guidance-key-updates-for-medical-devices-in-2026",
      "published": "2026-02-04",
      "updated": "2026-02-04"
    },
    {
      "title": "Navigating Data Privacy in 2026: Key Legislative Updates and Compliance",
      "url": "https://biggsb.com/blog/2026-02-03-navigating-data-privacy-in-2026-key-legislative-updates-and-compliance",
      "published": "2026-02-03",
      "updated": "2026-02-03"
    },
    {
      "title": "Algorithmic Governance in 2026: Navigating the Evolving AI Regulatory Landscape",
      "url": "https://biggsb.com/blog/2026-02-02-algorithmic-governance-in-2026-navigating-the-evolving-ai-regulatory-landscape",
      "published": "2026-02-02",
      "updated": "2026-02-02"
    },
    {
      "title": "2026 Pharmaceutical Manufacturing: Navigating Evolving FDA Standards",
      "url": "https://biggsb.com/blog/2026-02-01-2026-pharmaceutical-manufacturing-navigating-evolving-fda-standards",
      "published": "2026-02-01",
      "updated": "2026-02-01"
    },
    {
      "title": "Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026",
      "url": "https://biggsb.com/blog/2026-01-31-navigating-510-k-guidance-key-updates-for-medical-devices-in-2026",
      "published": "2026-01-31",
      "updated": "2026-01-31"
    },
    {
      "title": "Medical Device Reclassification in 2026: Navigating the Evolving Landscape",
      "url": "https://biggsb.com/blog/2026-01-27-medical-device-reclassification-in-2026-navigating-the-evolving-landscape",
      "published": "2026-01-27",
      "updated": "2026-01-27"
    },
    {
      "title": "Navigating Healthcare AI Regulations: Key Updates and Compliance in 2026",
      "url": "https://biggsb.com/blog/2026-01-25-navigating-healthcare-ai-regulations-key-updates-and-compliance-in-2026",
      "published": "2026-01-25",
      "updated": "2026-01-25"
    }
  ],
  "relatedSites": [
    {
      "name": "RegForge",
      "url": "https://regforge.ai",
      "description": "Compliance workflow software."
    },
    {
      "name": "SuperDain",
      "url": "https://superdain.com",
      "description": "DAIN, the regulatory AI agent used by BiggsB."
    }
  ],
  "formats": [
    {
      "name": "Company profile (Markdown)",
      "url": "https://biggsb.com/agents/company.md",
      "mediaType": "text/markdown"
    },
    {
      "name": "Company profile (JSON)",
      "url": "https://biggsb.com/agents/company.json",
      "mediaType": "application/json"
    },
    {
      "name": "Services (JSON)",
      "url": "https://biggsb.com/agents/services.json",
      "mediaType": "application/json"
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    {
      "name": "llms.txt summary",
      "url": "https://biggsb.com/llms.txt",
      "mediaType": "text/plain"
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    {
      "name": "Sitemap",
      "url": "https://biggsb.com/sitemap.xml",
      "mediaType": "application/xml"
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}