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
Mock FDA Inspections
CIRG conducts mock FDA inspections for medical device, in vitro diagnostic, biologics, and pharmaceutical manufacturers operating in Europe. These assessments simulate real FDA inspection approaches and help organizations identify compliance gaps before regulatory inspections occur.
FDA Inspection Readiness
We help European manufacturers prepare for FDA inspections by evaluating quality systems, documentation practices, manufacturing controls, and regulatory compliance programs. Our consultants assess inspection readiness and provide practical recommendations to strengthen compliance.
Regulatory Submissions and FDA Applications
Our team supports regulatory submissions, including 510(k) Premarket Notifications, Premarket Approval (PMA) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and other regulatory filings required for U.S. market access.
FDA Compliance and Quality System Support
CIRG assists manufacturers in developing and strengthening quality systems aligned with FDA regulatory requirements, including CGMP, Quality System Regulation (QSR), and global quality standards such as ISO-based systems.
CAPA and Regulatory Remediation
We assist organizations in evaluating corrective and preventive action (CAPA) systems, addressing regulatory observations, and strengthening quality management processes following FDA inspections or compliance reviews.
Supplier and Vendor Quality Audits
Our consultants conduct supplier and vendor audits to evaluate manufacturing controls, quality systems, and regulatory compliance across global supply chains supporting FDA-regulated products.
Regulatory Training and Inspection Preparation
CIRG provides training programs for management and quality teams covering FDA inspections, CGMP requirements, quality system expectations, and regulatory compliance practices.
Expert Insight from Former FDA Investigators
FDA consulting led by former investigators provides insight that is difficult to replicate externally. These professionals have conducted regulatory inspections, reviewed quality systems, evaluated manufacturing operations, and documented compliance observations based on direct interpretation of FDA regulations. This experience allows our consultants to anticipate inspection focus areas, identify potential compliance gaps, and help manufacturers strengthen regulatory readiness before an FDA inspection occurs.
Supporting Medical Device and Pharmaceutical Manufacturers
European manufacturers exporting regulated products to the United States must comply with FDA regulatory requirements. CIRG supports organizations that manufacture medical devices, in vitro diagnostics, biologics, and pharmaceutical products by helping them prepare for FDA inspections, strengthen quality systems, and maintain regulatory compliance.
Medical Device and In Vitro Diagnostic Manufacturers
We support manufacturers developing and producing medical devices and in vitro diagnostics that must comply with FDA regulatory requirements. Our consultants assist companies in evaluating quality systems, preparing for FDA inspections, addressing regulatory observations, and strengthening compliance programs.
Pharmaceutical and Biologics Manufacturers
CIRG provides regulatory consulting support to pharmaceutical and biologics manufacturers preparing for FDA inspections and regulatory submissions. Our consultants help organizations evaluate manufacturing controls, documentation systems, and compliance programs to align operations with FDA expectations.
Manufacturers Located Across Europe
CIRG works with manufacturers located throughout 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.
Organizations operating under European regulatory frameworks such as EU MDR, IVDR, and EMA requirements often require additional preparation when exporting products to the United States. Our consultants help bridge these regulatory differences and support companies preparing for FDA inspections.
Why European Manufacturers Need FDA Regulatory Guidance
Manufacturers located in Europe that export medical devices, in vitro diagnostics, biologics, or pharmaceutical products to the United States must comply with U.S. Food and Drug Administration (FDA) regulatory requirements. While many organizations operate under European regulatory frameworks such as EU MDR, IVDR, or EMA requirements, FDA inspections follow different compliance expectations, documentation practices, and inspection methodologies.
Key Differences Between European and FDA Regulatory Systems
FDA investigators evaluate manufacturing operations using risk-based inspection models and assess quality systems, production controls, laboratory practices, and regulatory documentation to determine compliance with U.S. regulations. These evaluations often focus on areas such as CAPA effectiveness, data integrity, process validation, complaint handling, supplier controls, and management responsibility.
Because regulatory systems in Europe and the United States are not identical, manufacturers may encounter compliance gaps when preparing for FDA inspections. FDA regulatory guidance helps organizations identify these gaps early, strengthen quality systems, and ensure that manufacturing operations align with FDA regulatory expectations before an inspection occurs.
For companies located in Switzerland, the United Kingdom, Germany, France, Italy, the Netherlands, Ireland, Denmark, Finland, Norway, Sweden, Belgium, Austria, and other European manufacturing regions, specialized FDA regulatory support can significantly improve inspection readiness and reduce regulatory risk when entering or maintaining access to the U.S. market.
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
Finding the right regulatory consulting firm is more challenging than many organizations expect. Numerous consulting companies and independent advisors offer FDA compliance support, each promising successful outcomes. However, for medical device, in vitro diagnostic, biologics, and pharmaceutical manufacturers, regulatory responsibility ultimately remains with the firm.
Selecting a consulting team with the appropriate regulatory experience is therefore critical.
At RAQA, our consultants bring both FDA and industry experience. Having worked within regulatory agencies as well as manufacturing environments, we understand how FDA investigators evaluate quality systems, manufacturing controls, and regulatory documentation. This perspective allows us to anticipate regulatory concerns and prepare organizations effectively for inspections and regulatory submissions.
Our FDA Consulting Services Include
Mock FDA inspections for medical device QSR, drug CGMP, OTC drugs, cosmetics, GLP, GCP, HACCP, ISO systems, and animal drug and feed manufacturers.
- Support during FDA inspections
- Supplier and vendor CGMP quality audits
- Recalls, removals, and field corrections
- Regulatory submissions including 510(k), PMA, NDA, ANDA, and other FDA applications
- Food additive petition submissions
- Review of FDA Warning Letters, Form 483 observations, and regulatory responses
- CAPA program evaluation and remediation
- CGMP, ISO, and quality system training
- Establishment registrations and product listings
- Review of standard operating procedures (SOPs) and quality system documentation
- Label and labeling reviews, including websites and dietary supplement labeling
- Quality management system (QMS) development and assessment
- Validation programs include computer systems, water systems (WFI and purified water), sterilization, cleanroom operations, aseptic filling, manufacturing processes, automation systems, software validation, and packaging validation.
FDA Experience Is Difficult to Replace
Qualified professionals with direct FDA regulatory experience are difficult to find. Our consultants provide practical regulatory insight developed through years of FDA compliance oversight and industry support.
Whether you require a short-term mock FDA inspection or long-term regulatory consulting support, our team can assist manufacturers worldwide. Contact us to discuss your regulatory 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 and inspection readiness goals.