# BiggsB Global > Practitioner-led consulting and execution partner for regulated organizations. 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. Canonical page: https://biggsb.com/about Agent View: https://biggsb.com/agents Schema version: 1.0 ## Company - **What we are:** A consulting firm that delivers hands-on regulatory, quality, validation and AI governance work, not a software vendor. - **Who we serve:** Pharmaceutical, biotech, medical device, clinical research and health technology organizations, and investors assessing regulated companies. - **How we work:** Remote-first and distributed, with no central office. Senior practitioners embed with your team in your time zone. - **Technology:** Our practitioners use regulatory technology including DAIN, rEGS and RegForge to work faster; people remain accountable for advice. ## Services ### AI Governance & Regulatory AI Consulting ID: `regulatory-ai` · Source: https://biggsb.com/services/regulatory-ai 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. **Who it is for** - 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 **Scope** - AI governance framework development: policy, roles, decision rights and accountability - AI use-case inventory and risk classification - Algorithmic impact assessments - Validation strategy for AI-enabled systems and model risk management - Cross-jurisdiction compliance strategy, including EU AI Act readiness - Responsible AI implementation and documentation **Typical deliverables** - AI governance policy and operating model - AI system inventory with risk ratings - Impact and risk assessment reports - Validation approach for AI-enabled systems, aligned to your quality system - Prioritized remediation and readiness roadmap **Boundaries:** BiggsB provides consulting and governance support. We do not sell AI products as part of this service, and our recommendations do not replace legal advice on specific statutory obligations. ### Computer System Validation & Computer Software Assurance ID: `compliance-validation` · Source: https://biggsb.com/services/compliance-validation 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. **Who it is for** - 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 **Scope** - Validation strategy and validation master planning - Risk-based validation using CSA and GAMP 5 principles - 21 CFR Part 11 and EU Annex 11 assessments - Requirements, risk assessment, test planning and execution oversight - Validation of SaaS, cloud and AI-enabled systems - Validation lifecycle management and periodic review **Typical deliverables** - Validation plan and risk assessment - Requirements and traceability documentation - Test protocols, executed evidence review and summary report - Part 11 / Annex 11 compliance assessment - Audit-ready documentation model your team can reuse **Boundaries:** We provide validation consulting and execution support. Final approval of validated status remains with your quality unit. ### Quality Systems, GxP Operations & Inspection Readiness ID: `gxp-clinical-operations` · Source: https://biggsb.com/services/gxp-clinical-operations 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. **Who it is for** - 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 **Scope** - QMS design, remediation and optimization - Quality assurance and quality control programs - Audit management, CAPA governance and audit defense - SOP development and training - Vendor qualification and oversight - Inspection readiness strategy, mock inspections and remediation **Typical deliverables** - QMS gap assessment and remediation plan - CAPA plans and effectiveness checks - Revised SOPs and training materials - Inspection readiness plan and mock inspection report - Vendor qualification framework **Boundaries:** We support your quality unit; responsibility for quality decisions and regulatory commitments stays with your organization. ### Clinical & Pre-Clinical Support ID: `clinical-preclinical` · Source: https://biggsb.com/services/clinical-preclinical 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. **Who it is for** - 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 **Scope** - Pre-clinical study design and oversight - IND (Investigational New Drug) and CTA (Clinical Trial Application) preparation and submission - Phase I–IV clinical trial management support - NDA (New Drug Application) and MAA (Marketing Authorisation Application) filing support - Post-market surveillance support **Typical deliverables** - Development and submission plan - Submission-ready documentation and review comments - Clinical oversight plans and trial documentation support - Post-market surveillance process support **Boundaries:** BiggsB supports sponsors; regulatory decisions and submissions remain the sponsor's responsibility. ### Veeva Implementation & Administration ID: `veeva-ecosystem` · Source: https://biggsb.com/services/veeva-ecosystem 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. **Who it is for** - Organizations implementing Veeva Vault applications - Teams that need ongoing Veeva administration capacity - Companies integrating Veeva with other clinical, quality or commercial systems **Scope** - Veeva Vault administration and configuration - CTMS (clinical trial management system) and CDMS (clinical data management system) implementation - Quality Docs and regulatory submissions configuration - Payments, analytics and system integrations - Validation support for Veeva configurations **Typical deliverables** - Configuration specifications and change records - Implementation plan and cutover support - Validation documentation for configured functionality - Administration runbooks and training **Boundaries:** BiggsB provides independent implementation and administration services and is not Veeva Systems. Licensing remains between you and Veeva. ### Fractional Executive Leadership ID: `fractional-leadership` · Source: https://biggsb.com/services/fractional-leadership 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. **Who it is for** - 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 **Scope** - Fractional Compliance Officer: compliance strategy, governance, board-level risk reporting and inspection readiness across FDA, GxP, HIPAA, HITRUST, GDPR and SOX-regulated environments - Head of Computer System Validation: Part 11 and Annex 11 compliance, risk-based validation (CSA / GAMP 5) and validation of AI-enabled systems - Head of Quality Assurance: QMS build and remediation, CAPA governance, audit defense and vendor oversight - Chief of AI & Compliance: AI governance, model risk management and AI regulatory strategy **Typical deliverables** - Function strategy and 90-day plan - Governance cadence and risk reporting for leadership - Prioritized remediation and capability roadmap - Hiring support and handover plan for a permanent leader **Boundaries:** Time commitment and decision authority are agreed in writing at the start of every fractional engagement. ### Regulatory & Technology Due Diligence ID: `due-diligence` · Source: https://biggsb.com/services/due-diligence 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. **Who it is for** - 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 **Scope** - Regulatory compliance review and gap analysis - Startup compliance maturity assessment - Technology and systems assessment, including validation status and data integrity - Operational due diligence and risk identification - Integration planning and post-merger regulatory support **Typical deliverables** - Due diligence findings report with risk ratings - Remediation roadmap with effort estimates - Investment risk summary for decision makers - Integration plan for regulated operations and systems **Boundaries:** Our diligence covers regulatory, quality and technology matters and complements, rather than replaces, legal and financial diligence. ### Additional capabilities - **Program & Portfolio Management:** Strategic program oversight, portfolio optimization, PMO establishment and governance, and performance management for complex regulated initiatives. - **Global Transformation:** Digital transformation strategy, operating model redesign, change management and cross-border integration for regulated organizations. - **Life Sciences & Healthcare Operations:** Clinical operations optimization, regulatory submission strategy, digital health initiatives and medical affairs support. ## Expertise 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. ## RegForge and related technology 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. - [DAIN regulatory assistant](https://biggsb.com/regulatory-assistant): Regulatory orientation with escalation to human experts. - [rEGS knowledge graph](https://biggsb.com/knowyourregs): Internal regulatory knowledge graph used by BiggsB practitioners. - [RegForge](https://biggsb.com/regforge): How RegForge compliance workflows relate to BiggsB engagements. - [Trust and AI use](https://biggsb.com/trust): How AI tools are used and where humans stay accountable. - [regforge.ai](https://regforge.ai) ## Contact - Contact page: https://biggsb.com/contact - Email: connect@biggsb.com - Book a consultation: https://calendly.com/biggsb-global_consultation - Expect a reply within one business day. - **DAIN intake:** 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. - **Contact form:** A classic contact form on the same page, for visitors who prefer not to use the intake assistant. - **Book a consultation call:** Schedule a consultation call directly through the booking page. - **Email:** Write to connect@biggsb.com. ## Resources - [Blog](https://biggsb.com/blog): Regulatory news and analysis. - [Guides and resources](https://biggsb.com/insights): Practical regulatory resources. - [How DAIN requests work](https://biggsb.com/how-it-works): How AI-assisted requests are reviewed by experts. - [Trust and AI use](https://biggsb.com/trust): How AI tools are used and where humans stay accountable. ### Recent articles - [Biotech Regulatory Shifts: Navigating the 2026 Landscape with BiggsB Global](https://biggsb.com/blog/2026-02-05-biotech-regulatory-shifts-navigating-the-2026-landscape-with-biggsb-global) (published 2026-02-05) - [Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026](https://biggsb.com/blog/2026-02-04-navigating-510-k-guidance-key-updates-for-medical-devices-in-2026) (published 2026-02-04) - [Navigating Data Privacy in 2026: Key Legislative Updates and Compliance](https://biggsb.com/blog/2026-02-03-navigating-data-privacy-in-2026-key-legislative-updates-and-compliance) (published 2026-02-03) - [Algorithmic Governance in 2026: Navigating the Evolving AI Regulatory Landscape](https://biggsb.com/blog/2026-02-02-algorithmic-governance-in-2026-navigating-the-evolving-ai-regulatory-landscape) (published 2026-02-02) - [2026 Pharmaceutical Manufacturing: Navigating Evolving FDA Standards](https://biggsb.com/blog/2026-02-01-2026-pharmaceutical-manufacturing-navigating-evolving-fda-standards) (published 2026-02-01) - [Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026](https://biggsb.com/blog/2026-01-31-navigating-510-k-guidance-key-updates-for-medical-devices-in-2026) (published 2026-01-31) - [Medical Device Reclassification in 2026: Navigating the Evolving Landscape](https://biggsb.com/blog/2026-01-27-medical-device-reclassification-in-2026-navigating-the-evolving-landscape) (published 2026-01-27) - [Navigating Healthcare AI Regulations: Key Updates and Compliance in 2026](https://biggsb.com/blog/2026-01-25-navigating-healthcare-ai-regulations-key-updates-and-compliance-in-2026) (published 2026-01-25) ## Formats - [Company profile (Markdown)](https://biggsb.com/agents/company.md) - [Company profile (JSON)](https://biggsb.com/agents/company.json) - [Services (JSON)](https://biggsb.com/agents/services.json) - [llms.txt summary](https://biggsb.com/llms.txt) - [Sitemap](https://biggsb.com/sitemap.xml) These files are BiggsB's own formats for convenience, not an industry standard.