/agents · directory
BiggsB Global: company reference
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.
This is a plain reference version of biggsb.com. It carries the same facts, service boundaries and contact details as the main site, generated from the same content.
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.
- Contact
- How to start a conversation · email connect@biggsb.com
Services
| Service | ID | Best for |
|---|---|---|
| AI Governance & Regulatory AI Consulting | regulatory-ai | Life sciences and healthcare organizations introducing AI into regulated processes |
| Computer System Validation & Computer Software Assurance | compliance-validation | Pharmaceutical, biotech and medical device companies implementing or upgrading GxP systems |
| Quality Systems, GxP Operations & Inspection Readiness | gxp-clinical-operations | Growing life sciences companies that need a QMS that scales |
| Clinical & Pre-Clinical Support | clinical-preclinical | Emerging biotech and pharmaceutical sponsors without a full internal regulatory team |
| Veeva Implementation & Administration | veeva-ecosystem | Organizations implementing Veeva Vault applications |
| Fractional Executive Leadership | fractional-leadership | Growth-stage and PE-backed companies that need mature compliance leadership |
| Regulatory & Technology Due Diligence | due-diligence | Private equity and venture investors evaluating life sciences or health technology companies |
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 — Regulatory orientation with escalation to human experts.
- rEGS knowledge graph — Internal regulatory knowledge graph used by BiggsB practitioners.
- RegForge — How RegForge compliance workflows relate to BiggsB engagements.
- Trust and AI use — How AI tools are used and where humans stay accountable.
- regforge.ai — Compliance workflow software.
- superdain.com — DAIN, the regulatory AI agent used by BiggsB.
Resources
- Blog — Regulatory news and analysis.
- Guides and resources — Practical regulatory resources.
- How DAIN requests work — How AI-assisted requests are reviewed by experts.
- Trust and AI use — How AI tools are used and where humans stay accountable.
Recent articles
- Biotech Regulatory Shifts: Navigating the 2026 Landscape with BiggsB Globalpublished
- Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026published
- Navigating Data Privacy in 2026: Key Legislative Updates and Compliancepublished
- Algorithmic Governance in 2026: Navigating the Evolving AI Regulatory Landscapepublished
- 2026 Pharmaceutical Manufacturing: Navigating Evolving FDA Standardspublished
- Navigating 510(k) Guidance: Key Updates for Medical Devices in 2026published
- Medical Device Reclassification in 2026: Navigating the Evolving Landscapepublished
- Navigating Healthcare AI Regulations: Key Updates and Compliance in 2026published
Contact
Start at the contact page, email connect@biggsb.com, or book a consultation call. Expect a reply within one business day.
Machine-readable files
- /agents/company.md — Company profile (Markdown)
- /agents/company.json — Company profile (JSON)
- /agents/services.json — Services (JSON)
- /llms.txt — llms.txt summary
- /sitemap.xml — Sitemap
These files are BiggsB's own formats for convenience, generated from the same content as the site. They are not an industry standard.
Page map
| Page | Human View | Agent View |
|---|---|---|
| Home | / | /agents |
| Services | /services | /agents/services |
| AI Governance | /services/regulatory-ai | /agents/services/regulatory-ai |
| CSV & CSA | /services/compliance-validation | /agents/services/compliance-validation |
| Quality & GxP | /services/gxp-clinical-operations | /agents/services/gxp-clinical-operations |
| Clinical & Pre-Clinical | /services/clinical-preclinical | /agents/services/clinical-preclinical |
| Veeva | /services/veeva-ecosystem | /agents/services/veeva-ecosystem |
| Fractional Leadership | /services/fractional-leadership | /agents/services/fractional-leadership |
| Due Diligence | /services/due-diligence | /agents/services/due-diligence |
| About | /about | /agents/about |
| Contact | /contact | /agents/contact |