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Pharmaceutical audit services

Q: How do you keep audits efficient for startups?

We apply a phase-appropriate, risk-based auditing model aligned with ICH Q9 (Quality Risk Management) and early-stage FDA IND / EU CTA expectations. We focus immediately on your highest-risk, critical-to-quality (CtQ) processes, utilize targeted interviews, and restrict document sampling to core Quality Management System (QMS) and data integrity essentials. Our goal is to secure compliance and inspection readiness without creating commercial-scale bureaucracy or paperwork your team cannot maintain.

Q: Can you support interaction with health authorities or notified bodies?

Yes. ADRES provides direct subject matter expert (SME) coaching and audit defense during FDA Pre-Approval Inspections (PAI), EMA site visits, and Notified Body audits (e.g., CE MDR / ISO 13485). We prepare your team to handle complex follow-up questions under pressure, actively join critical regulatory meetings, and draft technically robust, evidence-based responses to authority observations or FDA Form 483s to prevent findings from escalating.

Q: Do you offer remote audits?

Yes. We conduct highly thorough on-site, hybrid, and fully remote audits utilizing encrypted, secure digital frameworks—a vital solution for global multi-site teams or rapid due diligence. Our remote evaluations rigorously inspect electronic Quality Management Systems (eQMS), electronic Trial Master Files (eTMF), and Computer System Validation (CSV) protocols in strict alignment with FDA 21 CFR Part 11 and EU Annex 11 digital records guidance.

Q: What is the difference between an internal audit and a third-party audit?

Under ICH Q10 (Pharmaceutical Quality System), an internal audit (self-inspection) evaluates your own organization's QMS and Corrective and Preventive Action (CAPA) effectiveness to drive continuous operational improvement. Conversely, a third-party audit is an independent, legally mandated oversight assessment under EU GMP Chapter 7 and FDA 21 CFR 211.84, designed to qualify external vendors, CDMOs, and clinical CROs before onboarding or during active partnerships.

Q: What is included in the final audit report?

You receive an executive-level, risk-rated deliverable designed for both leadership and regulatory scrutiny. It includes an executive summary linking technical findings to business risk and patient safety, detailed observations mapped directly to governing regulatory clauses (e.g., specific FDA CFR, EU GMP, or ICH E6(R3) standards), structured root-cause analyses, and a prioritized CAPA remediation plan with clear ownership and verification timelines.

Q: Do you assess according to EU Annex 1 and data integrity guidance?

Yes. For sterile and aseptic manufacturing, we audit strictly against the revised EU GMP Annex 1 guidelines, evaluating Contamination Control Strategies (CCS), cleanroom behavior, and barrier systems. Simultaneously, all GxP audits embed rigorous data integrity evaluations adhering to ALCOA+ principles, FDA 21 CFR Part 11, and MHRA/EMA data governance guidance, focusing heavily on electronic audit trails and system access controls.

Q: What do you expect from us before the audit?

To ensure an efficient, one- to two-week turnaround, we request an initial point of contact, a site/facility list, and a high-level quality document set up front – including organizational charts, core QMS Standard Operating Procedures (SOPs), and relevant Quality Agreements. We then issue a streamlined preparation checklist and sampling plan so your internal teams and process owners can prepare without disruption.

Q: Can ADRES support audits across multiple regulatory markets at once?

Yes. We specialize in multi-market regulatory harmonization, consolidating compliance requirements for the FDA (US), EMA (Europe), MHRA (UK), and the Israeli Ministry of Health (MoH) into a single, unified audit execution. For medical devices, we leverage global frameworks like the MDSAP (Medical Device Single Audit Program) to evaluate cross-jurisdictional compliance simultaneously, dramatically reducing operational friction and audit fatigue.

Q: How often should we conduct audits?

Audit frequencies must be governed by ICH Q9 Quality Risk Management rather than rigid calendar schedules. Routinely, internal QMS self-inspections should occur at least annually. Critical vendor qualification audits (e.g., active CDMOs, API suppliers, and pivotal CROs))must be executed prior to onboarding and re-audited every two to three years based on risk. Finally, formal authority readiness audits should be scheduled six to nine months ahead of planned target date submissions or regulatory site inspections.

Pharmaceutical audits that stand up to inspectors

We prepare pharma, biotech, and medtech teams for inspections and audits. We focus on what inspectors actually check. We align your procedures, records, and training with real expectations so findings do not escalate.

Where we work? We work across the US, EU, Israel, the Gulf, and South America.

Standards we cover GMP, GDP, GCP, GLP, ISO 13485, EU MDR, and CSV, including 21 CFR Part 11.

An inspection is more than a regulatory formality, it is a test of trust in your systems. Regulators and customers expect clear evidence that risks are controlled and processes are reliable.

With ADRES, you get more than a checklist: you receive risk-based findings, practical CAPAs, and coaching that prepare your team for FDA, EMA, and notified body scrutiny. The result is an audit you approach with confidence and exit with trust intact.

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.

Strategic GxP Audit Frameworks: Risk-Based Comparison

Audit Framework	Governing Regulatory Standards	Strategic Objective & Core Focus	When to Engage ADRES
GCP Clinical & Sponsor Audit	ICH E6 (R2/R3)FDA 21 CFR Part 312 Declaration of Helsinki	Protecting patient safety & trial data integrity. Focuses on Trial Master File (TMF) contemporaneity, Source Data Verification (SDV), informed consent compliance, Transfer of Regulatory Obligasions (TORO) and rigorous oversight of clinical CROs and analytical testing laboratories.	• Prior to Phase II/III trial initiation.• When CRO/investigational site performance drops.• 6–9 months prior to clinical data submission (NDA/BLA/MAA).
GMP & Supplier Qualification Audit	FDA 21 CFR 211.84 EU GMP Chapter 7 (Outsourced Activities)ICH Q10	Mitigating supply chain & manufacturing risk. Verifies technical competence of CDMOs, API manufacturers, and critical material providers. Assesses aseptic processing (EU Annex 1 and FDA Guidance), change controls, and ensures binding Quality Agreements are enforced.	• Onboarding a new CDMO, facility, or critical vendor.• During active Tech Transfer phases.• When recurrent deviations or Out-of-Specification (OOS) results hint at systemic QMS gaps.
Mock FDA / EMA Inspection	ICH Q9 (Risk Management) ICH Q10 (QMS)FDA PAI Compliance Programs	Stress-testing QMS under inspection pressure. Simulates an official Pre-Approval Inspection (PAI) or routine authority visit. Identifies Critical-to-Quality (CtQ) vulnerabilities, coaches Subject Matter Experts (SMEs) in interview logistics, and establishes preemptive CAPA containment.	• Health authority or Notified Body audit is officially scheduled on the calendar.• Ahead of corporate due diligence, M&A, or institutional fundraising rounds.• Post-remediation verification.

How do you keep audits efficient for startups?

Can you support interaction with health authorities or notified bodies?

Do you offer remote audits?

What is the difference between an internal audit and a third-party audit?

What is included in the final audit report?

Do you assess according to EU Annex 1 and data integrity guidance?

What do you expect from us before the audit?

Can ADRES support audits across multiple regulatory markets at once?

How often should we conduct audits?

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!