Consulting & execution for regulated organizations
Regulatory expertise. AI governance. Hands-on execution.
BiggsB Global is a practitioner-led consulting partner for life sciences, healthcare and health technology organizations. We help teams govern AI responsibly, validate the systems they depend on, build quality systems that pass inspection, and fill senior compliance roles, then we do the work alongside them.
Who we serve
Pharmaceutical, biotech, medical device, clinical research and health technology teams, and the investors who back them.
What we deliver
Governance frameworks, validation evidence, remediated quality systems, submissions support and accountable leadership.
How we work
A distributed team of senior practitioners, embedded with you in your time zone, with no central office overhead.
Services
What BiggsB does
Seven core services, each led by people who have held the operational role themselves.
AI Governance & Regulatory AI Consulting
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.
Computer System Validation & Computer Software Assurance
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.
Quality Systems, GxP Operations & Inspection Readiness
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.
Clinical & Pre-Clinical Support
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.
Veeva Implementation & Administration
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.
Fractional Executive 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.
Regulatory & Technology 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.
- All services and additional capabilitiesView services hub
Where we help
Problems clients bring to us
AI is arriving faster than your controls
Teams want to use AI in regulated work, and quality needs a defensible way to say yes.
A system must be validated, and validation is slowing you down
New GxP systems, cloud migrations and SaaS platforms need risk-based evidence that stands up to inspection.
An inspection or audit is coming
Procedures, CAPA records and people need to be ready, and remediation needs an owner.
You need senior leadership before you can hire it
A fractional compliance, quality or validation leader can own the function now and build it for the long term.
AI expertise
Governing AI in regulated work
AI governance is a consulting service at BiggsB, not a product. We help organizations decide where AI can be used, classify its risk, set accountability, and validate AI-enabled systems with the same discipline applied to any GxP system.
AI governance consultingConsulting and software are different things
BiggsB delivers consulting engagements through its practitioners. Our team may use regulatory technology, including DAIN, rEGS and RegForge, to research and document faster, but people remain accountable for the advice and deliverables.
RegForge is compliance workflow software with its own home at regforge.ai. If you are evaluating software, start there; if you need people to do the work, start with us.
Engagement process
From first conversation to handover
- 01
Conversation
You describe the problem, timeline and constraints. We tell you honestly whether we are the right fit.
- 02
Scope
We agree outcomes, deliverables, roles and decision rights in writing before work starts.
- 03
Embedded delivery
Senior practitioners work inside your team and quality system, in your time zone.
- 04
Handover
We leave documentation and capability your team can maintain and defend.
What does BiggsB Global do?
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.
Which organizations are a good fit?
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.
How do BiggsB's services relate to RegForge?
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.
How does BiggsB work with clients?
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.
How can a prospective client start a conversation?
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
Regulatory news and practical guides
Analysis of regulatory developments, plus guides on AI governance, validation and quality leadership.
Next step
Discuss your project
Tell us what you are trying to achieve. A senior practitioner will reply to discuss scope, timing and whether BiggsB is the right fit.