Services

Regulatory, quality and AI governance services

BiggsB provides consulting and hands-on execution for regulated organizations. Each service below is delivered by practitioners who have held the role, working inside your team and quality system.

Discuss Your Project

BiggsB services, who they help and typical deliverables
Service	Best for	Typical deliverables
AI Governance & Regulatory AI Consulting	Life sciences and healthcare organizations introducing AI into regulated processes	AI governance policy and operating model; AI system inventory with risk ratings; Impact and risk assessment reports
Computer System Validation & Computer Software Assurance	Pharmaceutical, biotech and medical device companies implementing or upgrading GxP systems	Validation plan and risk assessment; Requirements and traceability documentation; Test protocols, executed evidence review and summary report
Quality Systems, GxP Operations & Inspection Readiness	Growing life sciences companies that need a QMS that scales	QMS gap assessment and remediation plan; CAPA plans and effectiveness checks; Revised SOPs and training materials
Clinical & Pre-Clinical Support	Emerging biotech and pharmaceutical sponsors without a full internal regulatory team	Development and submission plan; Submission-ready documentation and review comments; Clinical oversight plans and trial documentation support
Veeva Implementation & Administration	Organizations implementing Veeva Vault applications	Configuration specifications and change records; Implementation plan and cutover support; Validation documentation for configured functionality
Fractional Executive Leadership	Growth-stage and PE-backed companies that need mature compliance leadership	Function strategy and 90-day plan; Governance cadence and risk reporting for leadership; Prioritized remediation and capability roadmap
Regulatory & Technology Due Diligence	Private equity and venture investors evaluating life sciences or health technology companies	Due diligence findings report with risk ratings; Remediation roadmap with effort estimates; Investment risk summary for decision makers

Additional capabilities

These capabilities usually support a core engagement. Ask about them when you describe your project.

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.

Technology-enabled, people-accountable

Our practitioners may use regulatory technology, including DAIN, rEGS and RegForge, to research and document faster. These tools support our consulting; they are not what you are buying from BiggsB. For RegForge software, visit regforge.ai.

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.