Regulatory Affairs and FDA Consulting
About Us
CIRG Europe offers a different approach from traditional FDA consulting firms. Rather than providing one-time advice, we work as an extension of your regulatory and quality team through ongoing consulting support tailored to your organization. This model allows European medical device and pharmaceutical manufacturers to access experienced FDA regulatory expertise without the cost of hiring full-time specialists, while maintaining continuous FDA inspection readiness and compliance support.
Regulatory and Quality Expertise for Modern Manufacturers
Over the past several decades, the scope of FDA inspections and regulatory oversight has evolved significantly. In earlier years, a single FDA investigator might inspect medical device manufacturers, pharmaceutical facilities, food processing plants, and clinical research sites across a wide range of regulatory areas.
As manufacturing technologies advanced, regulatory oversight became increasingly specialized. Modern manufacturing environments now involve complex automated systems, advanced production processes, and highly technical quality systems that require deep expertise across multiple regulatory disciplines.
Increasing Complexity of Manufacturing and Compliance
With the adoption of automated manufacturing systems and advanced technologies, validation and quality system controls have become essential elements of regulatory compliance. These include areas such as sterilization validation, computer system validation, process validation, cleanroom validation, aseptic processing, and software validation.
Because of this complexity, it is no longer practical for a single regulatory professional to maintain expertise in every technical discipline involved in modern medical device or pharmaceutical manufacturing.
Regulatory Requirements and Global Standards
Regulatory frameworks such as FDA regulations under 21 CFR and international standards such as ISO-based quality systems have also evolved to address modern manufacturing technologies. These regulations require specialized expertise in regulatory affairs, quality assurance, validation, and compliance management.
As a result, many manufacturers seek professionals with dedicated experience in regulatory affairs, quality systems, validation programs, and FDA compliance.
Outsourcing Regulatory Affairs and Compliance Expertise
Hiring and maintaining a full team of regulatory affairs, quality assurance, validation, and compliance specialists can be costly and challenging, particularly for growing manufacturers or organizations preparing for FDA inspections.
Through CIRG Europe’s consulting model, manufacturers can access experienced FDA regulatory professionals who provide ongoing support for regulatory affairs, quality systems, and compliance programs.
Access to Experienced FDA Regulatory Professionals
Our team includes former FDA investigators, compliance officers, and regulatory professionals who understand how FDA inspections are conducted and how regulatory requirements are evaluated in practice.
By working with CIRG Europe, organizations gain access to experienced regulatory guidance without the need to maintain a full internal regulatory team.
A Practical Alternative to Building a Full Regulatory Department
For start-up companies and growing manufacturers in Europe and the United States, outsourcing regulatory affairs, quality assurance, and compliance support can provide a practical and cost-effective solution. This approach allows organizations to focus on product development and manufacturing while maintaining regulatory readiness and compliance oversight.
Your Ongoing FDA Regulatory Resource
Why Choose CIRG for FDA Consulting
Former FDA Investigators and Regulatory Experts
CIRG FDA Consulting Europe is composed of former FDA investigators, regulatory officials, and experienced quality assurance professionals with extensive knowledge of medical device and pharmaceutical regulatory compliance. Our team brings practical regulatory insight developed through years of inspection, compliance evaluation, and industry support.
Regulatory and quality teams often encounter complex or time-sensitive questions that require experienced guidance. When those situations arise, CIRG provides reliable access to regulatory expertise through ongoing consulting support. Our consultants are available by phone, email, video conference, or on-site visits when needed.
Through flexible monthly consulting arrangements, manufacturers can select a level of support that fits their operational needs. In most cases, our team responds to regulatory questions within 24 hours, helping organizations maintain regulatory clarity and inspection readiness.
Be Prepared for Unannounced FDA Inspections
FDA inspections are frequently conducted without advance notice, and manufacturers must be prepared to demonstrate compliance at any time. In 2025, the FDA expanded its approach to unannounced inspections, including increased use of these inspections at foreign manufacturing facilities supplying products to the United States, reinforcing inspection parity between domestic and international firms.
For this reason, medical device, in vitro diagnostic, biologics, and pharmaceutical manufacturers should maintain continuous inspection readiness rather than preparing only when an inspection is anticipated. FDA investigators may review quality systems, manufacturing controls, validation programs, CAPA effectiveness, and regulatory documentation during these inspections.
CIRG helps organizations maintain inspection readiness by identifying compliance gaps, strengthening quality systems, and preparing teams to respond confidently when FDA investigators arrive.
Benefits of Partnering with CIRG Europe
Through our ongoing consulting partnership model, manufacturers can access experienced FDA regulatory expertise with minimal travel requirements and efficient consulting costs. Key benefits include:
- Regulatory submissions preparation and support
- Mock FDA inspections and inspection readiness assessments
- Mock Remote Regulatory Assessments (RRA) aligned with FDA remote inspection practices
- On-site support during FDA inspections
- On-site regulatory and quality system training for staff
This partnership model allows organizations to obtain experienced FDA regulatory guidance while maintaining continuous inspection readiness and compliance support.
Additional Advantages of Our Consulting Partnership
International regulatory consulting can involve significant travel costs when specialized expertise must be brought to manufacturing facilities. CIRG Europe takes a practical approach to reduce unnecessary expenses while still providing experienced FDA regulatory support.
When possible, we coordinate consulting visits across multiple client engagements in the same region. By combining projects for manufacturers in Europe, the United Kingdom, Asia, and the United States, organizations can receive on-site regulatory support while sharing travel schedules and reducing overall costs.
In addition, many regulatory discussions and compliance questions can be handled remotely through phone calls, video conferences, or email consultations. This flexible model allows manufacturers to access experienced FDA regulatory guidance quickly while keeping consulting costs practical and sustainable.
Managing Director & Founder
Expertise:
- Mock FDA Inspection
- 21 CFR 4, 11, 210, 211, 803, 820
- CAPA Remediation
- Warning Letter & FDA-483 Responses
- Medical Device Regulation (MDR)
- ISO 13485, 11135
- 510(k), PMA Submissions
- NDA, ANDA Submissions
- Quality Assurance
- CE Marking
Managing Director & Founder
Andrew began his career with the U.S. Food and Drug Administration (FDA) shortly after completing his university education. Over the years, he developed extensive experience in both government and private industry around the world, giving him a comprehensive understanding of diverse regulatory environments.
During his time as an FDA Investigator, Andrew inspected a wide range of establishments, from start-up companies to some of the world’s largest medical device and pharmaceutical manufacturers. At the conclusion of these inspections, he issued numerous FDA Form 483 Inspectional Observations documenting deficiencies and regulatory deviations.
His work later expanded into regulatory enforcement when he served as an FDA Compliance Officer. In that role, he issued numerous Warning Letters (WL) and participated in official enforcement actions against firms that violated FDA laws and regulations, including international manufacturers exporting products to the United States.
Andrew later served as an FDA Supervisory Investigator, overseeing domestic and international senior investigators specializing in medical device and pharmaceutical inspections.
Following his government service, Andrew became a Principal Auditor and regulatory consultant, conducting mock FDA inspections for manufacturers across Asia, Europe, and the United States. He has also authored regulatory submissions on behalf of manufacturers, further demonstrating his global regulatory expertise.
Qualifications
- Managing Director
- Principal Auditor, Mock FDA Inspection
- Regulatory Affairs, FDA Consultant
- Ex-FDA Supervisory Investigator (SCSO)
- Ex-FDA Senior Compliance Officer
- Ex-FDA Medical Device Investigator
- Ex-FDA, Office of Regulatory Affairs, International Inspection Group, Medical Device
- Former Lieutenant Commander, US PHS
Flexible and Convenient Consulting Plans
FDA Consulting Partnership Plans
Low Risk 100
Ideal for well-established and experienced manufacturers or distributors producing lower-risk products. This plan provides ongoing regulatory and compliance support to help maintain FDA inspection readiness and address routine regulatory questions. Companies benefit from access to experienced FDA regulatory professionals who can provide guidance on quality systems, documentation practices, and regulatory requirements. The program helps organizations maintain compliance, respond to regulatory inquiries, and ensure continued readiness for potential FDA inspections.
Start Up 200
Ideal for start-up companies developing medical devices, in vitro diagnostics, or pharmaceutical products that require guidance in regulatory submissions and quality system development. This plan provides ongoing consulting support, regulatory training, and practical advice on FDA requirements, quality assurance programs, and compliance strategies. Companies benefit from access to experienced regulatory professionals who assist with early-stage regulatory planning, documentation development, and preparation for future FDA inspections and submissions.
Medium Risk 300
Our most popular plan is designed for well-established manufacturers operating medium-risk processes, such as Class II (non-sterile) medical device manufacturers, OTC drug manufacturers, and specification developers. This plan provides ongoing regulatory and quality system support to maintain FDA compliance and inspection readiness. Companies receive guidance on regulatory submissions, quality documentation, CAPA systems, and manufacturing controls, along with practical advice to address compliance questions and strengthen internal regulatory programs.
High Risk 400
Designed for manufacturers operating high-risk processes such as sterile manufacturing, aseptic processing, Water for Injection (WFI) systems, and complex validation environments, or for products requiring FDA approval and active pre-market or post-market regulatory oversight. This plan provides intensive regulatory and quality system support to help organizations manage complex compliance requirements, maintain inspection readiness, and address regulatory challenges involving manufacturing controls, validation programs, and regulatory submissions.
NOTE
Virtual consulting services are provided through phone, email, video conferencing, and scheduled correspondence with advance notice or appointment. Priority support may be given to high-risk matters or situations involving active regulatory inspections. Additional consulting hours may be requested and will be billed separately. Travel expenses may apply for on-site visits depending on the location of the manufacturing facility.
Connect with Us
Our team is always within reach. Connect with CIRG Europe to gain access to experienced regulatory professionals, including former FDA and EU officials, who understand how regulatory agencies evaluate compliance. Partner with CIRG Europe to strengthen your regulatory and quality strategies. Contact us to learn how our consulting partnership can support your organization’s FDA inspection readiness and regulatory compliance goals.