Audit and Mock Inspection Services Mock FDA Pre-Approval Inspection (PAI) Services

Pre-Approval Inspections (PAIs) are critical milestones in the regulatory process for pharmaceuticals, medical devices, and biologics. At The FDA Group, we offer comprehensive Mock PAI services to help you navigate this crucial step with confidence. Our team of experienced former FDA auditors provides realistic, thorough inspections that prepare your organization for the real thing.

Your product approval depends on PAI success

Pre-approval inspections are FDA's final verification before allowing your product to market. Unlike routine inspections, PAIs dive deep into specific products, processes, and data. FDA investigators verify that what you claimed in submissions matches reality—from development data through manufacturing capabilities to quality systems. One failed PAI can delay approval by months or years.

PAI readiness requires more than general compliance. You must demonstrate that specific products can be consistently manufactured, that submitted data is reliable and retrievable, and that your quality systems can support commercial production. Every claim in your submission becomes a potential inspection focus.

Our PAI readiness teams include former FDA investigators who've conducted hundreds of pre-approval inspections. We know which areas FDA scrutinizes, which questions they ask, and which findings delay approvals.

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Our mock PAI services include:

Submission claim verification and facility alignment
Development and tech transfer documentation review
Clinical and stability data audit trails
Manufacturing capability demonstrations
Process validation readiness assessment
Analytical method verification
Equipment qualification status review
Batch record and protocol preparation
Quality system readiness for commercial scale
Personnel training and competency verification
Supply chain and vendor readiness
Mock batch preparation exercises
FDA day simulation and team preparation

Key PAI focus areas we assess:

Data integrity for all submission elements
Scale-up and process validation
Facility fit for intended use
Quality unit oversight capabilities
Change control since submission
Commitment fulfillment
Commercial readiness

What is a mock PAI—and why are they critical?

A mock FDA Pre-Approval Inspection (PAI) is a simulated inspection process that a pharmaceutical or medical device company conducts internally or with the help of consultants before undergoing the official FDA inspection required for product approval. A mock PAI prepares the company for the actual FDA inspection by identifying and addressing any gaps or issues in its processes, facilities, documentation, or compliance that could lead to delays, regulatory action, or rejection of approval.

A mock PAI helps uncover any potential compliance gaps that might not be evident through regular internal audits. It ensures that processes related to GMP, quality systems, data integrity, and other regulatory requirements are fully aligned with FDA expectations.

Our mock inspectors also train staff on how to handle FDA investigators and ensure that all necessary documentation is in place and up-to-date. By resolving potential issues beforehand, a mock PAI ensures smoother FDA interactions, reduces the risk of surprises during the real PAI, and supports a predictable timeline for product approval.

We find that mock PAIs often lead to improvements in quality systems, SOPs, data controls, and personnel training, all of which are critical to maintaining compliance for both approval and long-term operations.

When mock PAIs should be performed:

Before Filing for Approval: Ideally, a mock PAI should be conducted shortly before the company files its New Drug Application (NDA), Biologics License Application (BLA), or Premarket Approval (PMA) with the FDA. This ensures that the company is fully prepared for the official PAI process.
As Part of Regular Inspection Preparedness: Companies often schedule mock PAIs well in advance of anticipated FDA inspections, especially if their facility has not been inspected recently or if there have been significant changes in their processes, personnel, or system
When Launching New Products: A mock PAI is critical when launching a new product, especially one that involves a new or modified manufacturing process, facility, or supply chain.
After Major Changes: Significant organizational or operational changes, such as the installation of new equipment, a new manufacturing line, or changes to quality systems, should trigger a mock PAI to ensure continued compliance with FDA standards.

Go deeper A Basic Guide to Mock FDA Inspections

Our in-depth guide covers the basics of mock FDA inspections, the reasons to conduct one, and exclusive best practices and recommendations from our team.

Read our mock FDA inspection guide »

Why choose The FDA Group?

We've helped hundreds of FDA-regulated firms of all sizes rapidly access the industry's best auditors to plan and conduct mock FDA inspections. We provide a timely, comprehensive, and enlightening audit experience that alleviates inspection stress and reveals every opportunity for improvement. If remediation is necessary and expert outside assistance is desired, we can continue providing that support as needed.

Our consultants simulate an actual FDA inspection at your site or facility, conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation and/or training projects.

Teams work with us to manage their inspection readiness when they’re ready for a higher level of professionalism and the peace of mind that comes with an auditing partner whose commitment to quality and integrity reflects their own.

Click to expand Our Mock PAI Services include:

PAI Preparation
- In-depth review of your documentation, including quality management systems, production records, and regulatory submissions
- Development of a tailored inspection plan based on your specific product and facility
- Briefing with your team to set expectations and explain the mock inspection process
On-Site Mock PAI Inspection
- Thorough facility tour mimicking FDA inspector's approach
- In-depth review of production processes, quality control measures, and documentation
- Interviews with key personnel across departments
- Real-time feedback and identification of potential issues
Comprehensive Reporting
- Detailed written report categorizing observations and deficiencies by criticality
- Clear explanation of each finding's regulatory basis
- Concrete recommendations for addressing identified issues
- Risk assessment of potential FDA responses to observed deficiencies
Follow-Up and Guidance
- Review of the report with your management team
- Strategic advice on prioritizing and addressing findings
- Guidance on developing effective CAPA plans
- Verification of the effectiveness of implemented corrective actions

Mock PAIs for Drug Manufacturing

Our drug-focused mock PAIs cover critical areas including, but not limited to:

Manufacturing processes and controls
- Validation of critical process parameters
- In-process controls and testing
- Process analytical technology (PAT) implementation
Laboratory controls and data integrity
- Review of analytical methods and their validation
- Assessment of LIMS
- Data integrity practices and audit trails
Facility and equipment systems
- Clean room classifications and environmental monitoring
- Equipment qualification and preventive maintenance programs
- Utilities systems (HVAC, water, compressed gases)
Material management systems
- Raw material testing and release procedures
- Supplier qualification and management
- Warehousing and inventory control practices
Packaging and labeling systems
- Label control procedures
- Packaging validation studies
- Serialization and track-and-trace compliance
Operational readiness
- Preparing for FDA investigators
- Personnel readiness and training
- Inspection logistics readiness

Mock PAIs for Medical Devices

For medical device manufacturers, our mock PAI assessments include, but are not limited to:

Design controls and risk management
- Design history file (DHF) review
- Risk analysis and mitigation strategies
- Design verification and validation protocols
Manufacturing process validation
- Installation, operational, and performance qualification (IQ/OQ/PQ)
- Process capability studies
- Validation of automated manufacturing systems
Quality system regulations (QSR) compliance (and QMSR compliance)
- Management responsibility and quality audits
- CAPA system effectiveness
- Complaint handling and MDR reporting procedures
Software validation (if applicable)
- Software development life cycle documentation
- Validation of manufacturing and quality system software
- Cybersecurity considerations for connected devices
Supplier management
- Supplier evaluation and qualification procedures
- Incoming inspection practices
- Management of contract manufacturers and specification developers
Operational readiness
- Preparing for FDA investigators
- Personnel readiness and training
- Inspection logistics readiness

Mock PAIs for Biologics

Our biologics-specific mock PAIs address unique considerations including, but not limited to:

Cell culture and fermentation processes
- Cell bank systems and characterization
- Bioreactor control strategies
- Media and supplement quality control
Purification and formulation procedures
- Chromatography and filtration validation
- Viral inactivation and removal steps
- Final formulation and fill/finish operations
Viral clearance and safety testing
- Viral clearance study designs and execution
- Adventitious agent testing programs
- TSE/BSE risk mitigation strategies
Stability testing and storage conditions
- Stability protocol design and execution
- Management of stability samples
- Definition and justification of shelf life
Lot release testing and product characterization
- Potency assay validation
- Impurity profile characterization
- Comparability studies for process changes
Operational readiness
- Preparing for FDA investigators
- Personnel readiness and training
- Inspection logistics readiness

Additional services include:

Compliance master planning and strategy
Corrective and preventive actions and implementation plans
Planning and execution of remediation projects
Validation and qualification
Quality system and corporate SOP guidance and development
Development of training programs

FDA Inspection Insights Inside FDA inspections with former FDA investigator Chris Smith

Watch our Q&A with one of our experienced former FDA consultants, where we address some of the most frequently asked questions about the FDA's PAI program and how to prepare accordingly.

Case study International PAI Audit Preparation & Remediation Project

Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union.

Read the case study (PDF) »

What makes us different Our auditors are industry experts and former FDA consultants

At The FDA Group, we pride ourselves on our deep bench of auditors, many of whom are former FDA professionals. Their intimate knowledge of the FDA inspection process and regulations provides invaluable insights and mimics the style of actual FDA investigators.

Our consultants simulate an actual FDA inspection at your site or facility, conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation projects.

Whether you're preparing for an internal mock inspection to evaluate your own facility or need to conduct an external mock FDA inspection of a supplier or vendor, our team of experienced consultants is ready to help.

Our Proven Process for Mock PAIs

Introductory Conversation

About Us
About You
Scope Of Work

Auditor Requirements

Backgrounds And Expertise
Location Of Resources
Rate Rightsizing

Agreement Processing

MSA And Addendums
Supplier Qualification
Pre-Scope Coordination

Proprietary Resource Selection

In-House Search For Auditors
Auditor Identification
Auditor Vetting

Auditor Presentation

Curriculum Vitae
Perfect Match Summary
Interview Call Coordination

Pre-Scope Auditor Meeting

Detail Gathering
Expectations Definition
Timelines And Deliverables

Dedicated Project Management

Audit Conduct
Checkpoint Communications
Total Quality Guarantee

VEEVA AUDIT MANAGEMENT SUPPORT Veeva eQMS data entry services

Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.

Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.

Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.

Why work with The FDA Group?

Exclusive life science focus and expertise
Dedicated account management team
Right resource, first time (95% success)
97% client satisfaction
Total Quality Guarantee

Read our brochure »

Contact us to prepare for your PAI

Submit the form below to schedule your Mock PAI or to learn more about how we can help ensure your regulatory success. Our team is ready to provide the expertise and support you need to navigate the Pre-Approval Inspection process with confidence. We respond within one business day.

Our resources can be utilized to meet the wide range of auditing requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

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