{ "schemaVersion": "1.0", "kind": "biggsb.services", "publisher": { "name": "BiggsB Global", "url": "https://biggsb.com/" }, "canonicalUrl": "https://biggsb.com/services", "agentViewUrl": "https://biggsb.com/agents/services", "note": "Generated from the same content as biggsb.com. Service descriptions do not carry tracked revision dates.", "services": [ { "id": "regulatory-ai", "name": "AI Governance & Regulatory AI Consulting", "shortName": "AI Governance", "topic": "AI governance consulting for life sciences", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "A team wants to deploy an AI tool in a GxP, clinical or patient-facing workflow", "Leadership needs an AI policy and decision rights before scaling pilots", "Customers, auditors or partners are asking how your AI is controlled", "New obligations such as the EU AI Act or FDA AI/ML expectations apply to your products" ], "scope": [ "AI governance framework development: policy, roles, decision rights and accountability", "AI use-case inventory and risk classification", "Algorithmic impact assessments", "Validation strategy for AI-enabled systems and model risk management", "Cross-jurisdiction compliance strategy, including EU AI Act readiness", "Responsible AI implementation and documentation" ], "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" ], "approach": [ { "title": "Assess", "description": "Map where AI is used or planned, who owns it, and which regulated processes it touches." }, { "title": "Design", "description": "Define proportionate controls, policies and validation expectations for each risk level." }, { "title": "Embed", "description": "Work with your quality, IT and business teams to put the controls into daily practice." }, { "title": "Hand over", "description": "Transfer ownership with documentation your team can maintain and defend." } ], "boundaries": "BiggsB provides consulting and governance support. We do not sell AI products as part of this service, and our recommendations do not replace legal advice on specific statutory obligations.", "faqs": [ { "question": "What does an AI governance engagement with BiggsB include?", "answer": "Typically an inventory of AI use, risk classification, a governance policy with clear decision rights, validation expectations for higher-risk systems, and a roadmap. Scope is set after an initial conversation about your systems and obligations." }, { "question": "Can you validate an AI-enabled system under GxP?", "answer": "Yes. We apply risk-based computer system validation practices to AI-enabled systems, including documented intended use, model risk management and ongoing performance monitoring appropriate to the risk." }, { "question": "Do we need a full framework before running an AI pilot?", "answer": "Not always. For early pilots we can define lightweight guardrails that let teams learn safely, then scale the framework as AI use becomes more material." } ], "related": [ { "id": "compliance-validation", "url": "https://biggsb.com/services/compliance-validation" }, { "id": "fractional-leadership", "url": "https://biggsb.com/services/fractional-leadership" }, { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" } ], "canonicalUrl": "https://biggsb.com/services/regulatory-ai", "agentViewUrl": "https://biggsb.com/agents/services/regulatory-ai", "contactUrl": "https://biggsb.com/contact" }, { "id": "compliance-validation", "name": "Computer System Validation & Computer Software Assurance", "shortName": "CSV & CSA", "topic": "computer system validation consulting", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "A new GxP system, cloud migration or major upgrade is scheduled", "An audit or inspection found gaps in validation or data integrity", "Validation is slowing releases and the team wants a risk-based approach", "You need to demonstrate 21 CFR Part 11 or EU Annex 11 compliance to a customer" ], "scope": [ "Validation strategy and validation master planning", "Risk-based validation using CSA and GAMP 5 principles", "21 CFR Part 11 and EU Annex 11 assessments", "Requirements, risk assessment, test planning and execution oversight", "Validation of SaaS, cloud and AI-enabled systems", "Validation lifecycle management and periodic review" ], "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" ], "approach": [ { "title": "Scope by risk", "description": "Agree intended use and critical functions so effort follows patient, product and data risk." }, { "title": "Plan", "description": "Set the validation strategy, deliverables and acceptance criteria up front." }, { "title": "Execute", "description": "Run or oversee testing with your team and vendors, resolving deviations as they arise." }, { "title": "Sustain", "description": "Leave a maintainable change-control and periodic-review model in place." } ], "boundaries": "We provide validation consulting and execution support. Final approval of validated status remains with your quality unit.", "faqs": [ { "question": "How does BiggsB support validation and quality teams?", "answer": "We can lead a validation program, fill specific roles such as validation lead or reviewer, or coach your team in risk-based methods. Our practitioners work inside your quality system rather than replacing it." }, { "question": "What is the difference between CSV and computer software assurance?", "answer": "Computer software assurance (CSA) is a risk-based way of approaching validation that focuses effort on features that affect product quality, patient safety and data integrity, rather than generating uniform documentation for every function." }, { "question": "How should we prepare for a validation project?", "answer": "Clarify the system's intended use, identify the business and quality owners, gather vendor documentation, and confirm which records and signatures are regulated. That preparation makes scoping faster and more accurate." } ], "related": [ { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" }, { "id": "regulatory-ai", "url": "https://biggsb.com/services/regulatory-ai" }, { "id": "veeva-ecosystem", "url": "https://biggsb.com/services/veeva-ecosystem" } ], "canonicalUrl": "https://biggsb.com/services/compliance-validation", "agentViewUrl": "https://biggsb.com/agents/services/compliance-validation", "contactUrl": "https://biggsb.com/contact" }, { "id": "gxp-clinical-operations", "name": "Quality Systems, GxP Operations & Inspection Readiness", "shortName": "Quality & GxP", "topic": "GxP quality and inspection readiness consulting", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "An inspection is expected or has been announced", "Audit findings or observations need a credible CAPA response", "Procedures are outdated, inconsistent or not followed in practice", "Quality is perceived as slowing the business rather than enabling it" ], "scope": [ "QMS design, remediation and optimization", "Quality assurance and quality control programs", "Audit management, CAPA governance and audit defense", "SOP development and training", "Vendor qualification and oversight", "Inspection readiness strategy, mock inspections and remediation" ], "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" ], "approach": [ { "title": "Diagnose", "description": "Review current processes, records and findings to identify the highest risks." }, { "title": "Prioritize", "description": "Agree a remediation sequence that addresses inspection risk first." }, { "title": "Remediate", "description": "Work alongside process owners to fix procedures, records and behaviors." }, { "title": "Rehearse", "description": "Prepare teams through mock inspections and storyboards so evidence is ready." } ], "boundaries": "We support your quality unit; responsibility for quality decisions and regulatory commitments stays with your organization.", "faqs": [ { "question": "Can BiggsB help us respond to inspection observations?", "answer": "Yes. We help analyze root causes, structure CAPA plans, draft responses for your review, and implement the remediation so commitments are met." }, { "question": "Do you only work with large quality teams?", "answer": "No. We often support growing companies that need to build quality capability for the first time, as well as established teams that need extra capacity." } ], "related": [ { "id": "compliance-validation", "url": "https://biggsb.com/services/compliance-validation" }, { "id": "fractional-leadership", "url": "https://biggsb.com/services/fractional-leadership" }, { "id": "clinical-preclinical", "url": "https://biggsb.com/services/clinical-preclinical" } ], "canonicalUrl": "https://biggsb.com/services/gxp-clinical-operations", "agentViewUrl": "https://biggsb.com/agents/services/gxp-clinical-operations", "contactUrl": "https://biggsb.com/contact" }, { "id": "clinical-preclinical", "name": "Clinical & Pre-Clinical Support", "shortName": "Clinical & Pre-Clinical", "topic": "clinical and pre-clinical regulatory support", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "A program is moving from pre-clinical work toward first-in-human studies", "A submission timeline is approaching and the team needs support", "Clinical trial oversight or documentation needs strengthening" ], "scope": [ "Pre-clinical study design and oversight", "IND (Investigational New Drug) and CTA (Clinical Trial Application) preparation and submission", "Phase I–IV clinical trial management support", "NDA (New Drug Application) and MAA (Marketing Authorisation Application) filing support", "Post-market surveillance support" ], "deliverables": [ "Development and submission plan", "Submission-ready documentation and review comments", "Clinical oversight plans and trial documentation support", "Post-market surveillance process support" ], "approach": [ { "title": "Plan", "description": "Align the development and regulatory strategy with program milestones." }, { "title": "Prepare", "description": "Build the documentation and evidence the next milestone requires." }, { "title": "Execute", "description": "Support study and submission execution alongside your team and partners." } ], "boundaries": "BiggsB supports sponsors; regulatory decisions and submissions remain the sponsor's responsibility.", "faqs": [ { "question": "Can BiggsB act as an extension of our clinical team?", "answer": "Yes. Practitioners can embed with your team for a defined phase of work, such as submission preparation or trial oversight." } ], "related": [ { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" }, { "id": "veeva-ecosystem", "url": "https://biggsb.com/services/veeva-ecosystem" }, { "id": "due-diligence", "url": "https://biggsb.com/services/due-diligence" } ], "canonicalUrl": "https://biggsb.com/services/clinical-preclinical", "agentViewUrl": "https://biggsb.com/agents/services/clinical-preclinical", "contactUrl": "https://biggsb.com/contact" }, { "id": "veeva-ecosystem", "name": "Veeva Implementation & Administration", "shortName": "Veeva", "topic": "Veeva Vault implementation and administration consulting", "summary": "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.", "idealClients": [ "Organizations implementing Veeva Vault applications", "Teams that need ongoing Veeva administration capacity", "Companies integrating Veeva with other clinical, quality or commercial systems" ], "whenClientsCall": [ "A Veeva implementation or migration is planned", "Internal Veeva administration capacity is stretched", "Configuration no longer reflects how the business works" ], "scope": [ "Veeva Vault administration and configuration", "CTMS (clinical trial management system) and CDMS (clinical data management system) implementation", "Quality Docs and regulatory submissions configuration", "Payments, analytics and system integrations", "Validation support for Veeva configurations" ], "deliverables": [ "Configuration specifications and change records", "Implementation plan and cutover support", "Validation documentation for configured functionality", "Administration runbooks and training" ], "approach": [ { "title": "Understand", "description": "Confirm the processes and records the platform must support." }, { "title": "Configure", "description": "Configure and document the platform with validation in mind." }, { "title": "Support", "description": "Provide administration support and transfer knowledge to your team." } ], "boundaries": "BiggsB provides independent implementation and administration services and is not Veeva Systems. Licensing remains between you and Veeva.", "faqs": [ { "question": "Do you provide ongoing Veeva administration?", "answer": "Yes. We can provide ongoing administration capacity or help you build your own internal administration function." } ], "related": [ { "id": "compliance-validation", "url": "https://biggsb.com/services/compliance-validation" }, { "id": "clinical-preclinical", "url": "https://biggsb.com/services/clinical-preclinical" }, { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" } ], "canonicalUrl": "https://biggsb.com/services/veeva-ecosystem", "agentViewUrl": "https://biggsb.com/agents/services/veeva-ecosystem", "contactUrl": "https://biggsb.com/contact" }, { "id": "fractional-leadership", "name": "Fractional Executive Leadership", "shortName": "Fractional Leadership", "topic": "fractional quality and compliance leadership", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "A senior quality or compliance role is vacant", "The business is growing faster than its compliance function", "The board or investors need clear risk reporting", "An inspection, audit or financing event needs senior ownership" ], "scope": [ "Fractional Compliance Officer: compliance strategy, governance, board-level risk reporting and inspection readiness across FDA, GxP, HIPAA, HITRUST, GDPR and SOX-regulated environments", "Head of Computer System Validation: Part 11 and Annex 11 compliance, risk-based validation (CSA / GAMP 5) and validation of AI-enabled systems", "Head of Quality Assurance: QMS build and remediation, CAPA governance, audit defense and vendor oversight", "Chief of AI & Compliance: AI governance, model risk management and AI regulatory strategy" ], "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" ], "approach": [ { "title": "Stabilize", "description": "Take ownership of urgent risks, commitments and stakeholder reporting." }, { "title": "Build", "description": "Put the policies, processes and team structure in place." }, { "title": "Transition", "description": "Support recruitment and hand over to a permanent leader when ready." } ], "boundaries": "Time commitment and decision authority are agreed in writing at the start of every fractional engagement.", "faqs": [ { "question": "What does fractional leadership involve?", "answer": "A senior practitioner takes on an executive role for an agreed portion of each week, owning the function's strategy and results, attending leadership meetings and directing the team, without a full-time hire." }, { "question": "When is fractional quality leadership appropriate?", "answer": "It suits organizations that need senior judgment now but do not yet need, or cannot yet attract, a full-time executive, including during growth, leadership transitions or inspection preparation." } ], "related": [ { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" }, { "id": "compliance-validation", "url": "https://biggsb.com/services/compliance-validation" }, { "id": "regulatory-ai", "url": "https://biggsb.com/services/regulatory-ai" } ], "canonicalUrl": "https://biggsb.com/services/fractional-leadership", "agentViewUrl": "https://biggsb.com/agents/services/fractional-leadership", "contactUrl": "https://biggsb.com/contact" }, { "id": "due-diligence", "name": "Regulatory & Technology Due Diligence", "shortName": "Due Diligence", "topic": "regulatory and compliance due diligence for life sciences", "summary": "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.", "idealClients": [ "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" ], "whenClientsCall": [ "A transaction is in diligence and regulatory risk is unclear", "A startup's compliance claims need independent assessment", "Post-close integration needs a regulatory and systems plan" ], "scope": [ "Regulatory compliance review and gap analysis", "Startup compliance maturity assessment", "Technology and systems assessment, including validation status and data integrity", "Operational due diligence and risk identification", "Integration planning and post-merger regulatory support" ], "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" ], "approach": [ { "title": "Scope", "description": "Agree the questions that matter for the investment decision and timeline." }, { "title": "Assess", "description": "Review documentation, systems and interviews to evidence findings." }, { "title": "Advise", "description": "Translate findings into risk, cost and timeline implications." } ], "boundaries": "Our diligence covers regulatory, quality and technology matters and complements, rather than replaces, legal and financial diligence.", "faqs": [ { "question": "Can you assess a startup's regulatory readiness for investors?", "answer": "Yes. We assess compliance maturity, identify gaps and estimate the remediation needed, so investors can factor regulatory readiness into the decision." } ], "related": [ { "id": "compliance-validation", "url": "https://biggsb.com/services/compliance-validation" }, { "id": "regulatory-ai", "url": "https://biggsb.com/services/regulatory-ai" }, { "id": "gxp-clinical-operations", "url": "https://biggsb.com/services/gxp-clinical-operations" } ], "canonicalUrl": "https://biggsb.com/services/due-diligence", "agentViewUrl": "https://biggsb.com/agents/services/due-diligence", "contactUrl": "https://biggsb.com/contact" } ], "additionalCapabilities": [ { "id": "program-management", "name": "Program & Portfolio Management", "description": "Strategic program oversight, portfolio optimization, PMO establishment and governance, and performance management for complex regulated initiatives.", "canonicalUrl": "https://biggsb.com/services#program-management" }, { "id": "global-transformation", "name": "Global Transformation", "description": "Digital transformation strategy, operating model redesign, change management and cross-border integration for regulated organizations.", "canonicalUrl": "https://biggsb.com/services#global-transformation" }, { "id": "life-sciences", "name": "Life Sciences & Healthcare Operations", "description": "Clinical operations optimization, regulatory submission strategy, digital health initiatives and medical affairs support.", "canonicalUrl": "https://biggsb.com/services#life-sciences" } ] }