Audit and Mock Inspection Services Regulatory Compliance Gap Analysis Services

Bridge the distance between your current state and regulatory expectations with targeted gap analysis audits that map deficiencies, quantify risks, and chart clear paths to compliance.

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Know exactly where you stand

Regulatory compliance isn't binary—it's a spectrum. Between full compliance and serious violations lies a range of gaps that vary in severity, risk, and remediation complexity. Understanding precisely where your organization falls on this spectrum is critical for prioritizing resources, planning improvements, and avoiding regulatory surprises.

Gap analysis audits go beyond simple compliance checking. They systematically compare your current quality systems, processes, and practices against applicable regulatory requirements, industry standards, and best practices. The output isn't just a list of deficiencies—it's a strategic roadmap that considers risk levels, resource requirements, and implementation sequences.

Our gap analysis specialists combine deep regulatory knowledge with practical remediation experience. We don't just identify gaps; we help you understand why they exist, what risks they pose, and how to close them efficiently.

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Our gap analysis audit approach includes:

  • Comprehensive regulatory requirement mapping
  • Current state documentation and practice review
  • Process observation and personnel interviews
  • Gap identification and categorization
  • Risk assessment and priority scoring
  • Root cause analysis for systemic issues
  • Remediation cost and timeline estimates
  • Quick-win opportunity identification
  • Resource requirement planning
  • Implementation roadmap development
  • Effectiveness measurement strategies
  • Ongoing compliance monitoring design

We assess your compliance against a comprehensive set of global regulatory requirements, including, but not limited to:

  • U.S. FDA regulations: 21 CFR Parts 210, 211, 600–680, 807, 812, 814, 820, 11, and applicable guidance documents.

  • EU and international regulations: EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, PIC/S GMP, and WHO standards.

  • ICH guidelines: Q8–Q11, E6, M4.

  • Applicable GxP standards across R&D, manufacturing, and clinical operations.

Click to expand Some of the regulatory frameworks we assess against

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U.S. FDA-Specific Regulations

General Frameworks

  • FDA Quality System Regulation (QSR) – 21 CFR Part 820, core GMP regulation for devices

  • FDA Quality Management System Regulation (QMSR) – Forthcoming modernization of QSR based on ISO 13485

  • 21 CFR Part 11 – Electronic Records and Electronic Signatures, foundational for data integrity and computerized systems

Drugs & Biologics

  • 21 CFR Part 210/211 – Current Good Manufacturing Practice (cGMP) for Drugs

  • 21 CFR Parts 600–680 – Biologics Regulations, including requirements for blood products, vaccines, allergenics, cellular and gene therapies

  • 21 CFR Part 312 – Investigational New Drug Applications (IND)

  • 21 CFR Part 314 – New Drug Applications (NDA)

  • 21 CFR Part 601 – Biologics License Applications (BLA)

Medical Devices

  • 21 CFR Part 807 – Registration and Device Listing

  • 21 CFR Part 812 – Investigational Device Exemptions (IDE)

  • 21 CFR Part 814 – Premarket Approval (PMA)

  • 21 CFR Part 820 – Quality System Regulation (QSR) (already listed above for completeness)

Data Integrity & Inspection Readiness

  • FDA Data Integrity Guidance – Including ALCOA+ principles

  • FDA Compliance Program Guidance Manuals (CPGMs) – Internal FDA playbooks for inspections and enforcement

International Regulations & Harmonization

  • ISO 13485:2016 – Medical Devices Quality Management Systems (core global QMS standard)

  • ISO 14971:2019 – Risk Management for Medical Devices

  • ISO 9001:2015 – General Quality Management Systems, sometimes paired with ISO 13485

  • ISO 14155:2020 – Good Clinical Practice for Medical Device Clinical Investigations

  • EU MDR/IVDR – Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746

  • EU GMP Guidelines (EudraLex Vol. 4) – cGMPs applicable to drugs and biologics in the EU

  • GxP Guidelines – GLP, GCP, GMP, and related standards across development and manufacturing

  • WHO Technical Report Series (TRS) – cGMP guidance used widely in emerging markets and by global health organizations

  • MDSAP (Medical Device Single Audit Program) – Unified audit approach accepted by FDA, Health Canada, TGA, ANVISA, PMDA

  • PIC/S GMP Guidelines – Pharmaceutical Inspection Co-operation Scheme, harmonized global GMP framework

  • Global Harmonization Standards – Including consensus standards recognized under IMDRF and international equivalency programs

ICH Guidelines (Including and Beyond Q10)

  • ICH Q10 – Pharmaceutical Quality System (already listed above, core to lifecycle GMP oversight)

  • ICH Q8(R2) – Pharmaceutical Development

  • ICH Q9 – Quality Risk Management

  • ICH Q11 – Development and Manufacture of Drug Substances

  • ICH E6(R3) – Good Clinical Practice (GCP) Guidelines

  • ICH M4 – Common Technical Document (CTD) for registration submissions

 

Gap Analysis Services Drug Manufacturing Gap Analysis Services

Our Drug Gap Analysis Audits are tailored to pharmaceutical manufacturers seeking to align their operations with FDA regulations and industry best practices. We assess compliance with 21 CFR Parts 210 and 211, ICH Q10, and applicable cGMP expectations across development and manufacturing. From laboratory controls to packaging operations, our audits map regulatory gaps, quantify risks, and provide practical remediation strategies.

Specific areas of focus include, but are not limited to:

  • Facility design and environmental controls
  • Equipment cleaning, maintenance, and calibration
  • Production and process control systems
  • Material receipt, testing, and inventory management
  • Laboratory controls and analytical method validation
  • Packaging and labeling systems
  • Batch record review and documentation practices
  • Stability studies and shelf-life programs
  • Change control and deviation management
  • Complaint handling and product recall readiness
  • Data integrity and electronic record controls (21 CFR Part 11)
  • Building and facilities assessment
  • Equipment maintenance and calibration review
  • Production and process control evaluation
  • Materials management and control systems
  • Laboratory control systems
  • Packaging and labeling controls
  • Warehouse and distribution practices
  • Returned and salvaged drug products handling
  • Complaint files and adverse event reporting systems

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GMP Auditing Medical Device Gap Analysis Services

Our Device Gap Analysis Audits support manufacturers in identifying and closing compliance gaps under 21 CFR Part 820, the FDA’s Quality System Regulation, and international standards such as ISO 13485:2016 and MDSAP. We assess design, manufacturing, and post-market systems to ensure product safety and regulatory preparedness throughout the device lifecycle.

Specific areas of focus include, but are not limited to:

  • Management controls and internal quality audits
  • Design and development planning (Design History File, risk management)
  • Document and record control systems
  • Supplier qualification and purchasing controls
  • Process validation and equipment qualification
  • Production and in-process inspection controls
  • Nonconformance handling and CAPA systems
  • Complaint files and MDR reporting procedures
  • Labeling, packaging, and UDI traceability
  • Installation, servicing, and statistical analysis

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GMP AUDITING Biologics Gap Analysis Services

Our Biologics Gap Analysis Audits address the specialized regulatory requirements of biological product manufacturing. We evaluate compliance with 21 CFR Parts 600–680, FDA guidance for CGMPs for biologics, and relevant sections of ICH and EMA expectations. From cell banking to viral clearance, our assessments offer a high-resolution view of system readiness and regulatory fit.

Specific areas of focus include, but are not limited to:

  • Biotech facility design and contamination control
  • Equipment cleaning, sterilization, and maintenance procedures
  • Environmental monitoring and aseptic processing controls
  • Raw material qualification and testing (including animal-derived components)
  • Cell line characterization and master cell bank systems
  • Upstream (cell culture, fermentation) and downstream (purification, filtration) processes
  • Viral clearance validation and biosafety measures
  • Product formulation and stability studies
  • Lot release testing and reference standards
  • Documentation controls and QA oversight
  • Compliance with CGTPs, if applicable (e.g., for HCT/Ps)

For companies developing vaccines, gene therapies, monoclonal antibodies, or blood-derived products, our biologics audits reveal the gaps that matter most—helping you prepare for inspections, support licensure, and protect patient safety.

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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.

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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

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Contact us today to learn more about our GMP auditing services.