Regulatory, quality and AI governance services

ID 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

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

Scope, approach, boundaries and FAQs →

ID 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

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

Scope, approach, boundaries and FAQs →

ID 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

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

Scope, approach, boundaries and FAQs →

ID 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

Typical deliverables

• -Development and submission plan
• -Submission-ready documentation and review comments
• -Clinical oversight plans and trial documentation support
• -Post-market surveillance process support

Scope, approach, boundaries and FAQs →

ID 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

Typical deliverables

• -Configuration specifications and change records
• -Implementation plan and cutover support
• -Validation documentation for configured functionality
• -Administration runbooks and training

Scope, approach, boundaries and FAQs →

ID 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

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

Scope, approach, boundaries and FAQs →

ID 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

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

Scope, approach, boundaries and FAQs →

• Program & Portfolio ManagementStrategic program oversight, portfolio optimization, PMO establishment and governance, and performance management for complex regulated initiatives.
• Global TransformationDigital transformation strategy, operating model redesign, change management and cross-border integration for regulated organizations.
• Life Sciences & Healthcare OperationsClinical operations optimization, regulatory submission strategy, digital health initiatives and medical affairs support.