Your Partner for Regulatory & Quality

Catalyst For Compliance

We streamline processes, reduce risk, and prepare you for every regulatory challenge.

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Your All-in-One Partner

for Regulatory, Quality, Auditing & Validation Success

We simplify compliance with end-to-end support across regulatory affairs, quality assurance, audits, and validation

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Top Regulatory & Quality Services- Ready When You Are

Whether you’re launching a product, navigating complex FDA or ISO requirements, or building out a robust QMS, our team of experts integrate seamlessly with your team to deliver results.

Compliance Starts Here—Audits & Validation Done Right

We specialize in getting it right the first time. Our expert team delivers thorough audits and reliable validation services—ensuring you meet regulatory requirements with confidence and efficiency.

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Our Core Services

THE AVENDIUM SOLUTION

Get access to all the different life science resources needed to accomplish your projects on-time and within budget.

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Audits

We perform and coordinate internal, external, and provider audits to verify quality

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Regulatory Affairs

We navigate complex regulations, streamline compliance processes, and ensure regulatory adherence for seamless market entry

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Quality Assurance

We ensure compliance, mitigate risks, and enhance product quality through expert services

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Validation Services

We ensure reliable performance of equipment, devices, and software through thorough commissioning and validation processes.

Client Testimonials

“Avendium has been a trusted extension of our team. Over the past several months, they’ve helped us build a strong, scalable quality management system that supports our day-to-day operations and positions us for further growth. Their practical guidance and deep understanding of the regulatory landscape have made a meaningful difference in how we approach quality.”

– Suzanne H., CEO at Pentara

“It was a pleasure working with the Avendium team. They provided expert guidance throughout the SOP development process and helped us align with best practices in quality management. Their insight into regulatory expectations and ability to translate that into actionable procedures added real value to our quality program. Their professionalism, responsiveness, and attention to detail ensured we ended up with high– quality SOPs that form a strong foundation for our quality management system.”

– Praveena T., QA Advisor at George Washington University

“Avendium was instrumental in helping us achieve ISO 9001 certification. From the initial gap assessment through SOP development, eQMS validation and implementation, training, and preparing us for and leading us through the certification audit —they guided us every step of the way. Their team was hands-on, knowledgeable, and felt like an extension of our own.”

– Todd U., CEO at Ross Southern Labs

Let’s discuss your next project

Achieve your goals with our tailored, results-driven strategies

9690 South 300 West 3rd Floor
Sandy, Utah 84070

+1 801 647 5802

info@avendium.com