CONTACT

Clear priorities and disciplined execution turn regulatory complexity into practical action. CIRG provides FDA Consulting to help manufacturers identify potential risks, strengthen quality systems, and prepare teams for Agency inspections. Our risk-based approach focuses attention on issues affecting product quality, operational control, and inspection readiness. Timely support can improve remediation planning and help teams use internal resources more effectively. No consultant can guarantee inspection outcomes or prevent enforcement. However, experienced guidance can help your organisation make informed decisions before concerns escalate.

Please complete the contact form with relevant details about your products, facility, regulatory needs, and preferred timing. For potential on-site services, include the site address, city, country, and requested scope. Please do not submit confidential or patient-identifiable information through the initial enquiry. CIRG is headquartered in San Francisco, California, and provides FDA Consulting worldwide. Subject to availability, we can travel throughout Europe, the United Kingdom, the Schengen Area, and other regions. When practical, we may coordinate regional visits for several companies to help manage travel costs while protecting client confidentiality. CIRG can also support organisations during Agency inspections, remotely or on-site. Availability cannot be guaranteed for urgent requests. Existing clients receive priority according to their engagement terms. We will review your enquiry and respond as soon as we are able.

RA QA Compliance
Contact RAQA by ex-FDA Investigator

LOCATIONS

    • San Francisco, California, USA
    • Zürich, Switzerland (Satelite)


    Partner With CIRG

    CIRG provides FDA Consulting across quality systems, regulatory compliance, CAPA remediation, and inspection readiness. Services include a mock FDA inspection and support for Form FDA 483 or Warning Letter responses. Led by a former FDA investigator, we understand how inspections develop and how evidence is evaluated. Our work emphasises practical advice, risk-based priorities, and evidence-supported actions. We help manufacturers identify potential risks, strengthen compliance programmes, and prepare clear responses. CIRG cannot guarantee regulatory outcomes, but we can help your team respond with control and confidence.