Strengthen Compliance and Quality with BioBoston Consulting’s Internal and Supplier Audits

In regulated life sciences markets, proactive auditing is the difference between resilient quality systems and costly compliance failures. BioBoston Consulting provides targeted internal audit services for pharma and supplier audit consulting that identify risk, close gaps, and build enduring compliance across your organization and supply chain.

What Internal and Supplier Audits Are

• Internal audits evaluate your Quality Management System, SOP adherence, batch records, training, CAPA, and readiness for external inspections.
• Supplier audits assess third-party manufacturers, raw material vendors, CROs, and service providers for GMP, GLP, and contractual compliance.
• Together they form a continuous monitoring loop that supports product quality, traceability, and regulatory trust.

Why Audits Matter for Life Sciences

• Regulatory readiness: Internal audits prepare teams for FDA, EMA, and ICH inspections.
• Supplier reliability: Supplier audits reduce supply disruptions, deviations, and recall risk.
• Risk mitigation: Early detection of nonconformities prevents downstream failures.
• Continuous improvement: Actionable findings feed CAPA and process optimization.
• Commercial confidence: Demonstrated oversight strengthens partnerships and investor trust.

BioBoston Consulting Audit Services

• Audit planning and protocols: Risk‑based audit schedules, checklists, and tailored scopes.
• Gap assessments and mock audits: Realistic simulations to surface high‑risk issues before regulators do.
• Supplier qualification and on‑site assessments: Vendor capability reviews, documentation checks, and remediation plans.
• Detailed audit reporting and CAPA management: Clear findings, root cause analysis, prioritized corrective actions, and closure verification.
• Training and remediation support: Auditor coaching, inspection response drills, and compliance enablement.

Each engagement is delivered by auditors with pharmaceutical, biotech, or device experience, ensuring practical, regulatory-aligned recommendations.

Typical Audit Process

1. Scope and risk assessment — Define audit objectives and critical areas.
2. Document review — Evaluate SOPs, records, and supplier dossiers.
3. On-site or remote assessment — Interviews, observations, and system checks.
4. Report and CAPA plan — Actionable findings with timelines and owners.
5. Follow-up and verification — Confirm corrective actions and sustained compliance.

Industries and Use Cases

• Pharmaceutical manufacturers and CMOs
• Biotech developers and biologics suppliers
• Medical device companies and component vendors
• CROs, CDMOs, and laboratory service providers
• Diagnostics and raw material suppliers

Services cover quality systems, manufacturing, laboratory controls, supply chain, clinical operations, and contract compliance.

Ready to Strengthen Compliance and Supplier Oversight

Partner with BioBoston Consulting for expert internal audit services for pharma and comprehensive supplier audit consulting that reduce regulatory risk and improve product quality. Book a gap assessment, schedule a mock audit, or request ongoing supplier oversight today.

Contact BioBoston Consulting now to arrange an audit program tailored to your regulatory landscape and business goals.