# BiggsB Global

> Practitioner-led consulting and execution partner for regulated organizations: regulatory consulting, AI governance, computer system validation, quality, clinical operations, and fractional executive leadership.

BiggsB Global is a consulting firm, not a software vendor. It works as a distributed team with no central office, embedding senior practitioners with clients in their time zones. Its practitioners may use regulatory technology such as DAIN, rEGS and RegForge; RegForge software is described separately at https://regforge.ai. Contact: connect@biggsb.com.

## Agent View

- [Agent directory](https://biggsb.com/agents): Plain reference version of the site with the same facts.
- [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)
- [Sitemap](https://biggsb.com/sitemap.xml)

## Services

- [Services overview](https://biggsb.com/services): All services, who they help and typical deliverables.
- [AI Governance & Regulatory AI Consulting](https://biggsb.com/services/regulatory-ai): AI governance and regulatory AI consulting for regulated organizations: governance frameworks, AI risk assessment, validation of AI-enabled systems and EU AI Act readiness.
- [Computer System Validation & Computer Software Assurance](https://biggsb.com/services/compliance-validation): Risk-based computer system validation and computer software assurance consulting for GxP systems, cloud platforms and AI-enabled software, aligned to 21 CFR Part 11 and EU Annex 11.
- [Quality Systems, GxP Operations & Inspection Readiness](https://biggsb.com/services/gxp-clinical-operations): Quality management system build and remediation, CAPA, audit management, SOP development and inspection readiness support for GxP-regulated organizations.
- [Clinical & Pre-Clinical Support](https://biggsb.com/services/clinical-preclinical): Support across the development lifecycle: pre-clinical study oversight, IND/CTA preparation, clinical trial management and NDA/MAA filing support.
- [Veeva Implementation & Administration](https://biggsb.com/services/veeva-ecosystem): Veeva Vault administration and configuration, CTMS and CDMS implementation, Quality Docs, regulatory submissions and system integrations.
- [Fractional Executive Leadership](https://biggsb.com/services/fractional-leadership): Fractional compliance officer, head of quality assurance, head of computer system validation and AI & compliance leadership for regulated organizations.
- [Regulatory & Technology Due Diligence](https://biggsb.com/services/due-diligence): Regulatory, compliance and technology due diligence for investors and acquirers in life sciences and health technology, including startup compliance readiness.

## Company

- [About BiggsB Global](https://biggsb.com/about): Company summary, how we work and contact route.
- [Discuss your project](https://biggsb.com/contact): Start a conversation through DAIN, the contact form or a booked call.

## 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.

## Optional

- [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.

## Related sites

- [RegForge](https://regforge.ai): Compliance workflow software.
- [SuperDain](https://superdain.com): DAIN, the regulatory AI agent used by BiggsB.