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FDA Regulatory Affairs and Compliance
In today’s global regulatory environment, maintaining effective FDA regulatory affairs and compliance programs can be challenging for both start-up and well-established manufacturers. Building and sustaining a full in-house team of specialists in regulatory affairs, quality assurance, and compliance is often resource-intensive. CIRG provides experienced regulatory professionals who function as an extension of your internal regulatory and quality teams. By helping manufacturers strengthen FDA regulatory compliance and well-structured quality systems, organizations are often better positioned to meet broader global regulatory expectations. Our team brings the experience, expertise, and practical regulatory insight needed to support your regulatory affairs and compliance activities whenever they are required.
What's New in 2026?
- Direct Reference to ISO 13485: Alignment with the Quality Management System Regulation (QMSR).
- Expanded Record Access: Preparing for the review of previously exempt Quality Audit reports.
- Removal of QSIT: Transitioning to the system-wide “Risk-Based” inspection model (CP 7382.850).
- Remote Regulatory Assessment (RRA) is a high-stakes examination—not a casual check-in.
- SME Interview Training: #1 “Human” element missing, as 90% of 483s are triggered by poor interview answers.
FDA Regulatory Affairs and Compliance Services
We provide regulatory and compliance support to help manufacturers align their operations with major global regulatory frameworks, including the United States Food and Drug Administration (FDA), MDSAP, ISO quality system standards, and European regulatory requirements. Our services focus on strengthening regulatory programs, improving quality systems, and helping organizations maintain compliance across multiple regulatory environments.
Regulatory Affairs
Quality Assurance
FDA & ISO Compliance
Key Features of Our FDA Consulting Services
Our FDA consulting services are designed to provide practical regulatory guidance, strengthen compliance programs, and support manufacturers in maintaining inspection readiness. The following features highlight how our team helps organizations manage regulatory responsibilities and navigate complex FDA requirements.
Regulatory Affairs Outsourcing
Our team of former FDA officials provides experienced regulatory guidance tailored to your organization’s needs. We support manufacturers in managing regulatory affairs responsibilities, strengthening compliance programs, and ensuring operations align with applicable regulatory requirements.
Comprehensive FDA Consulting
We provide comprehensive FDA consulting services to organizations regulated by the U.S. Food and Drug Administration, including medical device, in vitro diagnostic (IVD), pharmaceutical, biologics, BIMO, HCT/P, and combination product manufacturers, helping strengthen regulatory compliance and quality system oversight.
Medical Device, Drug, & Biologics
Our solutions are designed to address the unique regulatory and operational challenges of medical device, drug, and biologics manufacturing. We work closely with your organization to ensure regulatory activities integrate smoothly with existing standard operating procedures and quality system practices.
Ongoing FDA Consulting in Europe
We provide ongoing FDA consulting support to help manufacturers remain aligned with evolving regulatory requirements, ensuring operations stay compliant with applicable laws, regulations, and quality standards. Our team offers continuous guidance on regulatory questions, quality systems, and inspection readiness to support long-term compliance.
Who We Are
Former FDA Investigators & Reviewers
Our team includes former FDA investigators, compliance officers, reviewers, laboratory scientists, and regulatory managers with extensive experience in medical device and pharmaceutical inspections. Their knowledge of FDA laws and regulations provides practical guidance to help manufacturers maintain regulatory compliance and inspection readiness.
Medical Device & Pharmaceutical Industry Experts
Our team includes professionals with experience across medical device, biologics, in vitro diagnostics (IVD), combination products, HCT/Ps, and pharmaceutical manufacturing worldwide. Our Regulatory Affairs and Quality Assurance advisors work closely with your organization to ensure a smooth and effective partnership while supporting your regulatory and compliance needs.
FDA Laws, Regulations, and ISO Experts
We specialise in the U.S. Food and Drug Administration regulatory framework, including Title 21 of the Code of Federal Regulations (21 CFR), the Federal Food, Drug, and Cosmetic Act (FD&C Act), Current Good Manufacturing Practice (CGMP), international quality standards such as ISO, CE marking requirements, and the European Union Medical Device Regulation (EU MDR).
The margin for error is slim. Designate experienced regulatory experts.
Contact CIRG Europe today to discuss your regulatory needs or schedule a personalized consultation with our regulatory experts.
Designating Regulatory Affairs, Quality, and Compliance Functions
Searching for, hiring, and retaining experienced regulatory affairs and compliance professionals can be difficult and costly, particularly for start-up and growing medical device or pharmaceutical manufacturers. Organizations in the United States and Europe can designate their Regulatory Affairs, Quality Assurance, and Compliance functions to CIRG’s team of former FDA investigators, compliance officers, reviewers, and industry experts.
This consulting model provides a practical and cost-effective alternative to maintaining a full in-house regulatory department while helping companies avoid critical compliance mistakes. We frequently travel to Zurich, Switzerland, which allows manufacturers in the United Kingdom, EU/EFTA member states, and Schengen countries to access on-site regulatory support with minimal travel costs.
In addition, CIRG can support customer complaint handling operations for companies serving the U.S. market. Our team can operate a CAPA-aligned call center that follows your established procedures, including Customer Complaint Handling SOPs, Medical Device Reporting (MDR) requirements, and other CAPA-related processes.
Leading Experts in Regulatory Affairs, Quality Assurance, and Compliance
Our Mission
Our mission is to help medical device and pharmaceutical manufacturers achieve excellence in quality systems and regulatory compliance. We work closely with our clients to strengthen regulatory programs, improve operational practices, and support continuous compliance with FDA and global regulatory requirements. Through long-term partnerships, our consultants provide practical guidance that promotes innovation, protects patient safety, and helps organizations maintain strong quality and regulatory standards.
About CIRG
CIRG Europe is dedicated to helping manufacturers navigate complex regulatory and quality assurance requirements. With decades of combined experience, our team supports organizations in meeting the standards required by major health authorities, including the U.S. Food and Drug Administration. We combine practical regulatory expertise with a deep understanding of manufacturing operations to provide tailored solutions that strengthen compliance, quality systems, and inspection readiness.
Why Outsourcing Regulatory Affairs Is a Strategic and Economic Decision
The Strategic Advantage of Former FDA Expertise
Navigating the complex and constantly evolving FDA regulatory landscape can be one of the most resource-intensive challenges for medical device, pharmaceutical, and combination product manufacturers. Hiring and retaining in-house regulatory specialists—especially those with firsthand knowledge of FDA expectations—can be costly and sometimes ineffective due to limited inspection exposure or internal bias.
For this reason, many organizations rely on experienced external consultants led by former FDA officials. By designating your regulatory and compliance responsibilities to our consulting team, you gain more than outsourced support—you strengthen your regulatory strategy. Our experts, including former FDA Compliance Officers and seasoned investigators, provide practical insight into FDA expectations, how inspections are conducted, and how manufacturers can proactively reduce regulatory and enforcement risks.
We Don’t Just Interpret Regulations — We’ve Helped Write and Enforce Them
Our consulting approach is grounded in direct regulatory experience. Rather than relying solely on theoretical interpretation of FDA requirements, our team includes former FDA officials who have participated in inspections, enforcement actions, and regulatory decision-making. This experience provides manufacturers with practical insight into how regulations are applied during real inspections.
Maintaining a full in-house regulatory department can be costly and difficult, particularly when experienced regulatory professionals are in high demand. By partnering with CIRG Europe, organizations gain access to seasoned regulatory experts who have helped companies navigate FDA inspections, warning letter responses, and quality system remediation.
Our consultants work alongside your team as strategic partners, aligning regulatory compliance with your operational goals, timelines, and risk management strategies. This approach strengthens quality systems, improves inspection readiness, and helps organizations operate confidently under increasing regulatory scrutiny.