FDA Consulting by Former FDA Investigators
FDA Consulting
CIRG FDA Consulting provides regulatory advisory services to manufacturers in Switzerland, the United Kingdom, and elsewhere in Europe. Our team includes former Agency scientists, reviewers, investigators, compliance officers, and regulatory managers. Collectively, they offer experience in scientific review, inspections, compliance evaluation, and regulatory affairs.
We specialise in quality assurance and regulatory affairs for medical devices, in vitro diagnostics, biologics, and pharmaceutical products. Our consultants assess quality systems, identify potential gaps, and review documentation against applicable requirements. This work helps organisations strengthen compliance programmes and prepare their operations for Agency inspection.
Former investigators can explain how investigators trace records, interview personnel, and assess system implementation. They cannot speak for the Agency, predict enforcement decisions, or guarantee inspection outcomes. When appropriate, an FDA mock inspection can test personnel, records, and inspection procedures under realistic conditions. CIRG’s advice informs decisions, while each manufacturer remains responsible for its compliance.
FDA Inspection Readiness and Compliance Support
Long-term Agency inspection readiness requires more than a one-time assessment. European medical device, IVD, biologics, and pharmaceutical manufacturers may need continuing regulatory and quality support. CIRG offers retainer-based FDA Consulting for organisations seeking access to experienced professionals without creating another full-time internal position. Services remain subject to the engagement’s agreed scope, availability, and response arrangements.
Long-Term FDA Consulting Support
Our retainer programme supports manufacturers requiring regulatory advice, quality-system assistance, and inspection-readiness support throughout the year. Consultants can address routine questions, emerging compliance concerns, and planned regulatory activities. The arrangement does not transfer the manufacturer’s legal or regulatory responsibilities. Each organisation retains control over its quality system, submissions, and compliance decisions.
Continuous Inspection Readiness
A single mock FDA inspection provides a snapshot rather than continuing assurance. Readiness requires sustained attention to records, CAPA effectiveness, supplier controls, complaints, risk management, and management oversight. FDA Consulting can help organisations review these areas and monitor agreed remediation activities. However, the manufacturer remains responsible for implementing and verifying every correction.
Practical Support When Questions Arise
Quality and regulatory questions may arise between formal assessments. Examples include quality events, documentation gaps, inspectional observations, submission questions, and internal compliance decisions. Within the agreed engagement scope, CIRG provides access to advisers who can evaluate available facts and discuss practical options. Advice should rely on complete information and applicable current requirements.
An Alternative to Hiring Full-Time FDA Experts
Some manufacturers need periodic specialist support but do not require another full-time regulatory position. CIRG can offer a flexible alternative through a defined retainer arrangement. The engagement may provide access to former Agency professionals, subject to availability and documented qualifications. It does not replace qualified internal personnel, management oversight, or independent legal advice when required.
FDA Consulting Services Across Europe
CIRG supports European manufacturers seeking access to the United States market. Services cover medical devices, including IVDs, pharmaceutical products, and biological products. Each engagement follows an agreed scope based on the product, regulatory pathway, and organisation’s needs.
Expert Insight from Former FDA Investigators
FDA Consulting, led by a former investigator, provides practical insight into the FDA inspection methods. This professional has inspected facilities, reviewed quality systems, and evaluated manufacturing operations. That experience can help identify likely focus areas, potential gaps, and readiness priorities. Former service does not provide special access, influence, or certainty about inspection outcomes.
Mock FDA Inspection
FDA Consulting includes simulated inspections for manufacturers operating across Europe. A structured FDA mock inspection can test document retrieval, employee responses, manufacturing controls, and quality-system implementation. These assessments use published Agency procedures and applicable compliance programmes. They may identify potential gaps, but cannot reproduce every inspection or guarantee a particular outcome.
FDA Inspection Readiness
FDA Consulting helps European manufacturers evaluate their quality systems, documentation practices, manufacturing controls, and inspection procedures. Consultants identify potential weaknesses and provide prioritised recommendations. Each manufacturer remains responsible for determining applicability, implementing corrections, and maintaining continuing compliance.
Regulatory Submissions and Applications
FDA Consulting may support submissions for applicable United States regulatory pathways. Services may include 510(k) Premarket Notifications, De Novo requests, and Premarket Approval applications. Drug and biological product support may cover NDAs, ANDAs, INDs, and Biologics License Applications. Available support depends on the engagement’s scope and the team’s documented qualifications. Consulting cannot guarantee acceptance, clearance or approval.
FDA Compliance and Quality System
FDA Consulting can assist manufacturers with quality-system development, assessment, and remediation. For devices, the QMSR incorporates ISO 13485:2016 into 21 CFR Part 820. Drug and biological product manufacturers remain subject to applicable CGMP and product-specific requirements. Consultants should assess each operation against the regulations that actually apply.
CAPA and Regulatory Remediation
FDA Consulting can support reviews of CAPA systems, investigations, root-cause analyses, and effectiveness checks. A mock FDA inspection may test how teams investigate problems and connect corrective actions across systems. CIRG may also assist with responses to inspectional observations and remediation planning. The organisation retains responsibility for all commitments, corrections, and submissions to the Agency.
Supplier and Vendor Quality Audits
FDA Consulting may include supplier and vendor audits across global supply chains. Reviews can examine specifications, purchasing controls, quality agreements, change notifications, and supplier-monitoring activities. An audit does not certify regulatory compliance or transfer supplier-oversight responsibilities from the manufacturer.
Regulatory Training and Inspection Preparation
FDA Consulting includes training for management, quality teams, and relevant subject-matter experts. Topics may cover inspections, applicable CGMP requirements, QMSR expectations, document control, and communication practices. Training should reflect the organisation’s products, personnel responsibilities, and regulatory obligations. Attendance alone does not demonstrate compliance without effective implementation.
Pre-Approval and Pre-Licence Inspection Support
FDA Consulting supports facilities preparing for drug PAIs, biological product PLIs, and applicable PMA manufacturing inspections. An FDA mock inspection can examine commercial processes, application commitments, supporting data, validation, and quality-system controls. Consultants may identify potential gaps and recommend remediation priorities. However, the Agency determines whether an inspection is necessary, what it covers, and how its findings affect an application.
FDA Form 483 and Warning Letter Response
FDA Consulting helps organisations evaluate observations, investigate systemic causes, and prepare evidence-based corrective action plans. A timely, well-supported response may reduce the risk of unresolved concerns escalating. Form FDA 483 is not a final Agency determination. Consultants can strengthen the response, but cannot guarantee acceptance or prevent regulatory action.
Back-Room Advisory Support During FDA Inspections
FDA Consulting can provide experienced advisers for the back room during an active Agency inspection. Advisers help track requests, coordinate document retrieval, prepare subject-matter experts, and review proposed responses for accuracy. Consultants must not conceal information, alter records, encourage misleading answers, or create unreasonable delays. The organisation remains responsible for every record and response provided. Consultants should communicate directly with investigators only when management formally designates and introduces them.
Ongoing Quality Unit Support
FDA Consulting can supplement a quality unit with continuing regulatory and technical advice. Support may cover deviations, complaints, CAPA, change control, supplier concerns, management review, and inspection readiness. For drug manufacturers, consultants do not replace the quality control unit required by 21 CFR 211.22. The manufacturer retains authority over investigations, approvals, rejections, product release, and other quality decisions.
Validation Review and Assessment
FDA Consulting can review validation programmes against applicable requirements and the system’s intended use. Reviews may cover processes, cleaning, analytical methods, sterilisation, equipment, utilities, and computerised systems. FDA Consultant examines plans, protocols, acceptance criteria, source data, deviations, reports, and continued verification activities. They may identify potential deficiencies, but cannot establish a validated status without adequate objective evidence. The organisation remains responsible for approving, executing, and maintaining its validation programme.
Supporting Medical Device and Pharmaceutical Manufacturers
CIRG helps European manufacturers successfully navigate FDA regulatory requirements when exporting products to the United States. Our consultants support medical device, in vitro diagnostic (IVD), pharmaceutical, biologics, combination products, and contract manufacturing organizations (CMOs) by preparing them for FDA inspections, strengthening quality systems, and maintaining regulatory compliance.
Medical Device and In Vitro Diagnostic (IVD) Manufacturers
We support manufacturers of medical devices, in vitro diagnostics (IVDs), and software as a medical device (SaMD) that market products in the United States. Our consultants assist organizations with:
- FDA inspection readiness and mock FDA inspections
- FDA Quality Management System Regulation (QMSR) implementation
- Quality system gap assessments
- Design Control and Risk Management compliance
- CAPA, complaint handling, and post-market surveillance
- FDA Form 483 and Warning Letter response strategies
- Quality system remediation and management review
- Supplier quality and internal audit programs
Whether your organization is preparing for its first FDA inspection or strengthening an established quality system, CIRG helps ensure your organization is inspection-ready.
Pharmaceutical, Biologics, and Combination Product Manufacturers
CIRG provides FDA regulatory consulting for manufacturers of pharmaceuticals, biologics, APIs, sterile and non-sterile drug products, and combination products. Our consultants help organizations evaluate manufacturing operations and quality systems to meet FDA expectations, including:
- Current Good Manufacturing Practice (CGMP) compliance
- FDA inspection readiness and mock inspections
- Data integrity assessments
- Process validation and cleaning validation
- Documentation and record review
- Quality systems and CAPA effectiveness
- FDA Form 483 and Warning Letter remediation
- Executive inspection preparation and regulatory strategy
Our experience includes supporting manufacturers preparing for routine surveillance inspections, pre-approval inspections (PAIs), and follow-up FDA inspections.
Supporting Manufacturers Throughout Europe
CIRG works with manufacturers across Europe, including Switzerland, the United Kingdom, Germany, France, Italy, the Netherlands, Denmark, Finland, Norway, Sweden, Ireland, Belgium, Austria, Poland, Spain, Portugal, and other European manufacturing regions.
Many European companies already comply with EU MDR, IVDR, ISO 13485, ISO 14971, GMP, and EMA requirements. However, FDA expectations differ in several important areas. CIRG helps bridge these regulatory differences by providing practical guidance based on firsthand FDA inspection experience, allowing organizations to prepare confidently for U.S. regulatory inspections and maintain ongoing compliance.
Understanding the Differences Between European and FDA Regulatory Systems
Although European and FDA regulatory systems share many quality principles, significant differences exist in regulatory expectations, inspection methodology, documentation, and enforcement. FDA investigators conduct risk-based inspections to determine whether products are manufactured in compliance with U.S. laws and regulations. Depending on the product type, inspections may evaluate areas including:
- Quality Management System Regulation (QMSR)
- Current Good Manufacturing Practice (CGMP)
- Corrective and Preventive Action (CAPA)
- Design Controls
- Process Validation
- Data Integrity
- Complaint Handling
- Supplier Controls
- Management Responsibility
- Production and Process Controls
- Laboratory Controls
- Internal Audits
- Purchasing Controls
Even manufacturers with mature quality systems operating under European regulations may encounter FDA compliance gaps if they are unfamiliar with FDA inspection expectations.
Preparing for FDA Inspections Before They Occur
Early FDA inspection preparation allows manufacturers to identify compliance gaps before an FDA investigator arrives. A comprehensive mock FDA inspection and quality system assessment can strengthen inspection readiness, reduce regulatory risk, and improve confidence throughout the inspection process. CIRG helps manufacturers understand how FDA investigators evaluate compliance, identify areas requiring improvement, and implement practical corrective actions before an official FDA inspection.
Whether your company is located in Switzerland, the United Kingdom, Germany, France, Italy, the Netherlands, Belgium, Ireland, Denmark, Finland, Norway, Sweden, Austria, Poland, Spain, Portugal, or elsewhere in Europe, our consultants provide FDA regulatory expertise to help organizations successfully prepare for U.S. market access and maintain ongoing FDA compliance.
We’ve been there and done that!
Extensive FDA compliance experience, including drafting Warning Letters, evaluating firm responses to FDA Form 483 observations, and participating in enforcement actions such as product seizures and injunctions.
Choosing the Right FDA Consulting Firm
Selecting the right FDA consulting firm is one of the most important decisions a regulated manufacturer can make. Numerous consulting firms and independent consultants offer FDA regulatory support, each promising successful outcomes. However, regardless of the consultant you hire, regulatory responsibility always remains with the manufacturer.
For medical device, in vitro diagnostic (IVD), pharmaceutical, biologics, combination product, food, dietary supplement, cosmetic, and veterinary manufacturers, choosing consultants with the appropriate FDA regulatory experience is critical to achieving and maintaining compliance.
At CIRG, our consultants bring experience from both the FDA and industry. Having worked within the FDA as well as regulated manufacturing environments, we understand how FDA investigators evaluate quality systems, manufacturing operations, laboratory controls, documentation, and management responsibility during inspections. This unique perspective allows us to anticipate regulatory concerns, identify compliance gaps, and help organizations prepare effectively for FDA inspections and regulatory submissions.
Our FDA Consulting Services Include
Our FDA consulting services include support for manufacturers worldwide, including:
- Mock FDA inspections for medical devices, pharmaceuticals, biologics, in vitro diagnostics (IVDs), OTC drugs, cosmetics, dietary supplements, food manufacturers, GLP, GCP, HACCP, ISO quality systems, and animal drug and feed manufacturers
- On-site and remote support during FDA inspections
- Supplier and vendor CGMP quality audits
- Product recalls, removals, and field corrections
- FDA regulatory submissions, including 510(k), PMA, De Novo, NDA, ANDA, IDE, and other FDA applications
- Food additive petition submissions
- FDA Form 483, Warning Letter, and regulatory response review
- CAPA program evaluation, remediation, and effectiveness verification
- CGMP, QMSR, ISO 13485, and quality system training
- FDA establishment registration and product listing assistance
- Review and development of standard operating procedures (SOPs) and quality system documentation
- Labeling and promotional material review, including websites, instructions for use (IFUs), and dietary supplement labeling
- Quality Management System (QMS) development, implementation, and assessment
- Validation support for computer systems, software, manufacturing processes, sterilization, cleanrooms, aseptic processing, purified water and WFI systems, automation systems, packaging, and laboratory operations
FDA Experience Is Difficult to Replace
Professionals with direct FDA regulatory experience are uncommon. Our consultants provide practical insight developed through years of FDA inspection, compliance oversight, enforcement activities, and industry consulting. This experience enables us to provide practical, risk-based recommendations that help manufacturers strengthen compliance while preparing for FDA inspections.
Whether your organization requires a one-time mock FDA inspection, assistance responding to FDA observations, or long-term regulatory consulting support, CIRG provides practical FDA expertise to help manufacturers worldwide achieve inspection readiness and maintain regulatory compliance.
Contact us to discuss your FDA regulatory and compliance needs.
Contact Our FDA Consulting Europe Team
European manufacturers often assume that working with experienced FDA consultants requires significant travel expenses or long-term contracts. CIRG takes a more practical approach.
Although many of our consultants are based in the United States, we frequently travel to Europe to support manufacturers preparing for FDA inspections and regulatory compliance programs. When multiple consulting engagements are scheduled during the same travel period, we are often able to coordinate visits with several manufacturers. This approach can significantly reduce travel costs while still providing direct on-site support when needed.
Our consulting model is designed to provide practical regulatory expertise without the excessive costs often associated with large consulting firms. Many organizations find that our experience, combined with a more efficient consulting structure, allows them to access former FDA regulatory expertise at a more reasonable cost than traditional consulting arrangements.
Whether you require ongoing FDA consulting support, a mock FDA inspection, or assistance preparing your organization for regulatory inspections, our team is available to discuss your needs.
Contact our FDA consulting team to learn how CIRG can support your organization’s regulatory compliance, FDA inspection readiness, and long-term regulatory goals.