Regulatory Affairs and FDA Consulting
About Us
CIRG Europe offers ongoing FDA Consulting as an alternative to one-time advisory engagements. We work alongside regulatory and quality teams through support tailored to each organisation. This model gives European medical device, IVD, pharmaceutical, and biological product manufacturers access to experienced regulatory advice. Companies can obtain specialist support without creating another full-time internal position. Our consultants address emerging questions, assess potential risks, and strengthen inspection readiness between formal reviews. Each manufacturer retains responsibility for its quality system, compliance decisions, and inspection outcomes.
Regulatory and Quality Expertise for Modern Manufacturers
Over recent decades, Agency inspections have become more product-specific and technically focused. Historically, some field investigators covered several regulated product areas. Today, specialised offices and compliance programmes guide inspections for particular products, systems, and risks. Modern facilities use automation, complex software, advanced processes and integrated quality systems. Effective FDA Consulting often requires coordinated regulatory, quality, engineering and scientific expertise.
Increasing Complexity of Manufacturing and Compliance
Automation does not create one universal validation requirement. Manufacturers must determine the necessary controls and evidence for each product, process, and intended use. Relevant areas may include sterilisation validation, process validation, aseptic processing, cleanroom qualification, and computerised-system assurance. Few individuals maintain deep expertise across every technical discipline. Effective FDA Consulting coordinates appropriate specialists while keeping responsibility and decision-making with the manufacturer.
Regulatory Requirements and Global Standards
Different product categories remain subject to different requirements. Applicable finished-device manufacturers follow the QMSR, which incorporates ISO 13485:2016. Drug manufacturers follow relevant CGMP requirements, including 21 CFR Parts 210 and 211. Biological product manufacturers may also face product-specific requirements under Parts 600 through 680. International standards do not replace applicable United States law. FDA Consulting should identify the correct requirements before recommending controls or remediation. An FDA mock inspection can test whether systems, records, and personnel demonstrate compliance under realistic conditions. Consultants can support readiness, but manufacturers retain responsibility for compliance.
Outsourcing Regulatory Affairs and Compliance Expertise
Building internal teams across regulatory affairs, quality assurance, validation, and compliance may require substantial resources. Growing manufacturers may need specialised support while preparing for an Agency inspection or a mock FDA inspection. CIRG Europe provides FDA Consulting through flexible, defined engagements. Manufacturers can access regulatory and quality expertise without creating every role as a full-time internal position. Each engagement should define its scope, responsibilities, availability, and deliverables.
Access to Experienced FDA Regulatory Professionals
FDA Consulting may provide access to a former Agency investigator and qualified regulatory, quality, and validation specialists. Their experience can support inspections, quality-system assessments, and the practical application of relevant requirements. Consultants advise the organisation; they do not speak for the Agency. Manufacturers should verify qualifications and remain responsible for all records, decisions, and compliance activities.
A Practical Alternative to Building a Full Regulatory Department
FDA Consulting can supplement internal teams through project-based or continuing support. This model may suit start-ups and growing manufacturers across Europe and the United States. Outsourcing does not transfer regulatory responsibility or replace required quality-unit authority, qualified personnel, or management oversight. Organisations can focus internal resources while retaining control over product quality, regulatory decisions, and compliance.
Your Ongoing FDA Regulatory Resource
Why Choose CIRG for FDA Consulting
Former FDA Investigator and Regulatory Expertise
CIRG Europe’s FDA Consulting is led by a former FDA investigator and supported by experienced regulatory and quality professionals. The team advises medical device, IVD, biologics, and pharmaceutical manufacturers within each consultant’s area of expertise. First-hand inspection experience helps teams understand how investigators trace records, assess controls, and evaluate supporting evidence. However, this experience does not provide special access, influence Agency decisions, or guarantee inspection outcomes. Clients can request support by telephone, email, video conference, or an agreed-upon on-site visit. Monthly arrangements can cover regulatory questions, quality-system concerns, and inspection preparation.
Service availability and response times depend on the engagement terms, urgency, and consultant schedules. CIRG works alongside internal teams, while each manufacturer retains responsibility for its compliance decisions and regulated activities.
Prepare for Announced or Unannounced Agency Inspections
Inspection notice varies by programme, purpose, location, risk, and operational requirements. The Agency may preannounce certain domestic or foreign inspections. Other inspections may begin without advance notice. In May 2025, the Agency announced plans to expand unannounced inspections at foreign manufacturing facilities. The initiative aims to strengthen consistency between domestic and international oversight. Manufacturers should therefore maintain continuous readiness instead of relying on advance notice. An FDA mock inspection can test record retrieval, communication, and cross-functional responses under realistic conditions.
FDA Consulting can also review quality systems, manufacturing controls, validation, CAPA, and regulatory documentation. The applicable scope depends on the product, operation, and inspection type. Preparation may reduce preventable weaknesses and improve inspection performance. However, no consultant can guarantee compliance, inspection findings, or protection from regulatory action.
Benefits of Partnering with CIRG Europe
Through FDA Consulting, manufacturers can access targeted regulatory, quality, and validation support under clearly defined engagement terms. Remote delivery may reduce travel, while on-site work remains available when the scope and schedule require it.
Key services include:
- Regulatory submission strategy, preparation, and document review
- A mock FDA inspection and inspection-readiness assessment
- Remote inspection exercises and preparation for an Agency Remote Regulatory Assessment
- Remote or on-site back-room advice during an Agency inspection
- Regulatory and quality-system training for personnel
These services supplement internal expertise; they do not transfer the manufacturer’s regulatory or quality responsibilities. Engagement terms should define scope, availability, confidentiality, and deliverables.
Flexible Remote and On-Site Support
International regulatory projects may involve substantial travel when specialised expertise must be provided at a manufacturing facility. CIRG Europe uses remote support where appropriate and plans on-site work around each engagement’s needs. When scheduling permits, CIRG Europe may coordinate regional travel across separate client engagements. Any allocation of travel expenses should be agreed in advance and documented for each client. Client information and project details remain confidential and are not shared between organisations.
Many regulatory questions can be addressed through telephone calls, video conferences or secure document reviews. On-site support may remain appropriate for facility walkthroughs, specialised assessments, or live inspection assistance. FDA Consulting combines these delivery methods according to scope, urgency, confidentiality, and consultant availability. This approach may control travel expenses, although CIRG cannot guarantee savings or a particular regulatory outcome.
Managing Director & Founder
Managing Director & Founder
Andrew began his regulatory career at the U.S. Food and Drug Administration shortly after completing university. His subsequent private-sector work broadened his experience across several international regulatory environments. As an FDA investigator, Andrew inspected medical device and pharmaceutical establishments of different sizes. When warranted, he documented Form FDA 483 observations and presented them to management. These observations identified conditions that, in his judgement, might violate applicable requirements.
Andrew later served as an FDA Compliance Officer. He helped develop and review Warning Letters and supported recommendations concerning other regulatory actions. His career subsequently advanced to a supervisory investigator role. He supervised personnel involved in domestic and international medical device and pharmaceutical inspections.
Following his FDA service, Andrew became a principal auditor and regulatory consultant. He has conducted FDA mock inspection engagements across Asia, Europe, and the United States. His FDA Consulting work includes submission support, quality-system assessments, CAPA remediation, validation review, and inspection preparation.
Qualifications
- Managing Director and Founder
- Principal Auditor for FDA mock inspection services
- Principal, FDA Consulting
- Former FDA Supervisory Investigator
- Former FDA Senior Compliance Officer
- Former FDA Medical Device Investigator
- Former member of the FDA Office of Regulatory Affairs International Inspection Group
- Former Lieutenant Commander, U.S. Public Health Service Commissioned Corps
Expertise:
- FDA Consulting and inspection readiness
- Mock FDA inspection planning and execution
- 21 CFR Parts 4, 11, 210, 211, and 820 (QMSR)
- Medical Device Reporting under 21 CFR Part 803
- CAPA investigation and remediation
- Form FDA 483 and Warning Letter response support
- EU MDR, Regulation (EU) 2017/745, and CE marking
- ISO 13485 and ISO 11135
- 510(k), PMA, NDA, and ANDA submission support
- Quality assurance and validation review
FLEXIBLE REGULATORY SUPPORT PLANS
FDA Consulting Partnership Plans
Base 100
Established manufacturers and distributors with defined systems may need occasional regulatory and quality support. FDA Consulting may cover routine document reviews, quality-system questions, and continuing inspection readiness. A periodic mock FDA inspection can test whether procedures, records, and actual operations remain aligned. This plan suits organisations seeking scheduled support rather than continuous project management. It does not imply that the organisation or its products present low risk. Scope depends on regulated activities, product types, and agreed deliverables.
Start-Up 200
Start-ups developing medical devices, IVDs, drugs, biologics, or combination products often need early regulatory direction. FDA Consulting may support pathway planning, quality-system development, submission preparation, validation strategy, and personnel training. Early guidance can help teams identify requirements before design or manufacturing decisions become difficult to change. The applicant and manufacturer remain responsible for submissions, product quality, and compliance decisions.
Established 300
Established manufacturers with regular regulatory and quality needs may require broader support. FDA Consulting may address CAPA, complaints, supplier controls, validation, manufacturing controls, change management, and submissions. An FDA mock inspection can evaluate document retrieval, staff responses, and system connections before an Agency inspection. This tier may suit Class II device, OTC drug or specification-development operations. However, product category alone does not determine the appropriate plan. CIRG should confirm the scope after reviewing operational complexity and support needs.
Complex 400
Manufacturers managing technically complex or resource-intensive work may need concentrated regulatory and quality support. FDA Consulting may cover sterile or aseptic processing, Water for Injection systems, complex validation, remediation, and premarket support. Support may also include back-room advice during an Agency inspection, subject to agreed scope and availability. Services do not guarantee approval, clearance, inspection results, or protection from regulatory action. Selection should reflect actual operations, product requirements, deadlines, and continuing support needs.
NOTE
FDA Consulting services are available by telephone, email, video conference, and scheduled meetings. Urgent support may be prioritised for active FDA inspections or other time-sensitive matters. Availability and response times remain subject to the engagement terms and consultant schedules. CIRG will perform and invoice additional hours only after the client authorises them. On-site engagements may incur reasonable travel expenses based on location and project requirements. CIRG will disclose estimated charges and obtain approval before booking, unless agreed otherwise in writing.
Connect with Us
Contact CIRG Europe to discuss your regulatory and quality needs. Our professionals include a former Agency investigator with direct inspection and compliance experience. FDA Consulting can support regulatory strategy, quality systems, inspection readiness, and mock FDA inspection preparation. Tell us about your products, facilities, and anticipated timelines. We will review your enquiry and respond as soon as scheduling allows.