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Ensure your facility passes FDA inspections with confidence. Our experienced team provides comprehensive preparation, documentation review, and on-site support.

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Don’t wait until the last minute. Our proactive approach ensures your facility is always inspection-ready.

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Industries We Serve

Biologics

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Cosmetics

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Dietary Supplement

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Medical Devices

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FDA inspection readiness services

Pet Food & Animal Health

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Pharmaceuticals

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Comprehensive FDA Compliance Services

From preparation to post-inspection support, we provide end-to-end solutions to ensure your facility meets all FDA requirements and maintains compliance.

Pre-Inspection Preparation

Comprehensive facility audits, documentation review, and gap analysis to ensure complete readiness.

On-Site Inspection Support

Expert consultants present during inspections to provide guidance and ensure smooth interactions with FDA officials.

CAPA Development

Corrective and Preventive Action plan development for addressing inspection findings and preventing recurrence.

Training Programs

Staff training on FDA regulations, GMP compliance, and inspection preparedness for your entire team.

Documentation Systems

Design and implementation of robust documentation systems that meet FDA requirements and best practices.

24/7 Emergency Support

Round-the-clock support for urgent compliance questions and emergency inspection notifications.

  • Need a Custom Solution?

Every facility is unique. We provide tailored consulting services to address your specific compliance challenges and regulatory requirements.

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Your Trusted Partner in

FDA Compliance

With over 15 years of experience in FDA regulatory compliance, our team of former FDA inspectors and industry experts has helped hundreds of facilities successfully navigate complex regulatory requirements.

We understand the challenges you face because we’ve been there. Our practical, results-driven approach ensures your facility not only passes inspections but maintains ongoing compliance excellence.

  • Former FDA inspectors on our team with insider knowledge
  • Proven methodologies tested across diverse industries
  • Ongoing support to maintain compliance between inspections
  • Expert Team

Our team brings decades of combined experience from both regulatory and industry perspectives.

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Facilities Served

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Success Rate

15+

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Our Blogs

Healthcare professional using a tablet to monitor human anatomy data via a digital interface.
Inspections

Medical Device Inspection Program QMSR Requirement

Navigating the transition from QSR to QMSR is critical for medical device manufacturers. This comprehensive guide explores the medical device inspection program QMSR requirement, offering deep insights into 21 CFR 820 harmonization with ISO 13485. Discover actionable strategies for audit readiness, risk management, and avoiding common FDA 483 observations in the evolving regulatory landscape of 2026.

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February 19, 2026 No Comments
QMSR inspection program SOP sample documentation with digital QMS dashboard and medical equipment.
Inspections

QMSR Inspection Program SOP Sample for FDA/ISO

Transitioning to the FDA’s new Quality Management System Regulation (QMSR) requires a robust Standard Operating Procedure (SOP). This guide provides a comprehensive QMSR inspection program SOP sample, integrating ISO 13485:2016 requirements with FDA oversight. Learn how to manage internal audits, handle regulatory investigators, and maintain 21 CFR 820 compliance to avoid 483 observations in 2026.

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February 19, 2026 No Comments
Doctor analyzing a digital brain model on a tablet for medical device QMSR inspection readiness.
Inspections

Medical Device QMSR Inspection Program Template

Transitioning from QSR to QMSR is a critical step for manufacturers. This comprehensive guide provides a medical device QMSR inspection program template, covering audit readiness, ISO 13485 alignment, and FDA expectations to help you avoid 483 observations and maintain seamless regulatory compliance in the evolving global landscape.

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February 19, 2026 No Comments
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Inspections

QMSR Inspection Program Checklist for Medical Devices

Transitioning to the Quality Management System Regulation (QMSR) is a major shift for the medical device industry. This comprehensive guide provides a detailed QMSR inspection program checklist to help manufacturers harmonize their quality systems with ISO 13485. Learn how to manage risk, ensure data integrity, and pass FDA inspections with confidence in 2026.

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February 19, 2026 No Comments
Healthcare professionals analyzing real-time clinical data on a high-tech digital monitor for QMSR compliance.
Inspections

Step-by-Step Medical Device Inspection Program for QMSR Compliance

Transitioning to the Quality Management System Regulation (QMSR) is a major milestone for medical device manufacturers. This guide provides a step-by-step medical device inspection program for QMSR compliance. Learn how to align your quality systems with ISO 13485, integrate risk management, and pass FDA inspections with confidence in 2026.

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February 19, 2026 No Comments
A regulatory consultant explaining QMSR implementation steps to a medical device manufacturer representative.
Inspections

How to Implement Medical Device Inspection Program QMSR

Transitioning to the Quality Management System Regulation (QMSR) is a critical step for manufacturers. This guide explains how to implement medical device inspection program QMSR effectively. By focusing on risk management and international harmonization, you can ensure your facility remains audit-ready and compliant with the latest FDA expectations in 2026.

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February 19, 2026 No Comments

Get Expert FDA Consultation

Don’t face your next FDA inspection alone. Contact our experts today for a confidential consultation and ensure your facility is ready.

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If you’ve received an FDA inspection notice, don’t panic. Our rapid response team can help you prepare quickly and effectively.
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FDA Inspections

Your trusted partner for FDA compliance and inspection readiness. With former ex-FDA’ers  on our team, we provide the expertise and confidence you need to succeed.

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