Pharmaceutical audit services

What you get

• Audit plan and scope tailored to your product/service and lifecycle stage. Clear timing and owners.
• Readiness review mapped to the relevant standards and guidance.
• Risk-rated findings with practical fixes your team can implement.
• Structured CAPA plan with owners, due dates, and effectiveness checks.
• Coaching for interviews, logistics, and evidence presentation.
• Optional mock inspection to test your response under time pressure.

When to bring us in

• Authority inspection, notified body audit, or customer audit on the calendar.
• New facility, supplier, or clinical site that needs qualification.
• Recurrent deviations or observations that hint at systemic gaps.
• Due diligence ahead of partnerships or fundraising.
• Need to assess vendor and supplier quality systems.
• QMS needs a stress test before FDA, EMA, or MoH visits.
• Desire to improve operational consistency and risk mitigation.

How we work

1. Scope and plan

• Define audit type and standards in scope. Examples include GMP for manufacturing and analytical labs, GLP for animal facilities and bioanalytical labs, GDP for distribution, GCP for clinical research, and ISO 13485 and MDR for medical devices.
• Identify processes, systems, and records that will provide objective evidence.
• Build a plan that fits the time available and your risk profile.

2. Assess and evidence

• Document review. QMS, validation, training, change control, deviations, complaints, supplier controls, and study documentation when relevant.
• On-site or remote interviews with process owners and study staff.
• Sampling and traceability from requirements to records.

3. Report and close gaps

• Findings written in clear language with a reference to the requirement that triggered each observation.
• We call out immediate fixes when appropriate.
• CAPA plan that includes containment, correction, and prevention. We add owners, dates, and verification steps.
• Executive readout that links risk to product quality and patient safety.

Audit in clinical research

Clinical research has unique risks and evidence flows. We audit sponsors, CROs, investigational sites, and vendors with the goal of protecting subjects and preserving data integrity. We align with and track changes in ICH E6, so expectations are current.

Focus areas

• Trial Master File sampled for contemporaneity, not just completeness.
• Informed consent process and documentation.
• Source data verification and data integrity controls.
• Safety reporting and escalation pathways.
• Investigator responsibilities and delegation logs.
• IP management, storage, and accountability.
• Vendor oversight, including laboratories.

Deliverables

• Site or CRO audit report with risk-rated findings.
• Follow-up CAPA plan that fits study timelines.
• Coaching for teams ahead of sponsor or authority visits.
• Templates your team can reuse for ongoing TMF health checks.

Supplier and internal audits

• Supplier qualification and surveillance. Fit-for-purpose checks for CMOs, warehousing, and critical material providers.
• Internal audits. Independent review of your QMS, including data integrity and CSV, to prepare for external scrutiny.
• Mock inspections. Dress rehearsals that test your responses and documentation under time pressure.
• Hybrid and multi-market audits. Consolidated audits across multiple markets to streamline global compliance.

What makes this effective

• We connect findings to business risk. Leadership gets a simple view of what to fix and why it matters.
• We align remediation with how your team actually works. Procedures become usable. Training is targeted and brief.
• We write in the language your regulators use so your responses land.
• We leave you with templates and checklists your team can reuse.

Why ADRES

• Global experience. Audits across Europe, North America, South America, and Asia.
• Integrated services. Tie audits into Inspection Readiness, Regulatory Affairs, and Quality Assurance.
• Flexible delivery. On-site or remote audits adapted to your operational model.
• Customized reports. Actionable insights and CAPA recommendations tailored to your organization.

Engagement options

• Targeted readiness check. One to two weeks. Single site or function.
• Full audit with CAPA management. Three to six weeks, depending on the scope.
• Ongoing support. Monthly retained support for multi-site programs.

If you have an audit date on the calendar or a new site to qualify, send us the context and timeline. We will propose a focused plan within one business day. NDA available on request. Contact us today to get started!