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What Sets Us Apart

Quantus holds a deep-seated understanding of the rigorous compliance and quality standards governing 503A and 503B compounding pharmacies. Our services are specifically designed to meet the complex needs of this industry, ensuring that every facility operates beyond the required regulatory frameworks. With our swift and dependable scheduling, your facility can anticipate and plan for essential certifications and validations without delay. Our reports have garnered recognition from the FDA for their clarity and thoroughness, offering you an added layer of confidence in the compliance and integrity of your operations.

Leveraging our in-depth expertise in microbial environmental monitoring and sterility validation, we deliver not just results, but the assurance and knowledge that empower you to operate at the industry's forefront. By choosing Quantus, you’re investing in a service that places your facility on the map for excellence and reliability.

 

Certification • Microbial EM • Sterility Validation

Onsite Services

  • Cleanroom Certification

    Cleanroom Certification

    Providing industry-compliant certification services for PECs, cleanrooms, biological safety cabinets, and sterile processes, ensuring compliance.

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  • Environmental Monitoring

    Environmental Monitoring

    Sampling services for controlled environments: air, surface, personnel, chemical,  water, and compressed gas sampling. Ensure safety and compliance with regulatory standards.

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  • Autoclave Validation

    Autoclave Validation

    GMP-Grade Autoclave and Oven Validation Services.Ensuring Uncompromised Sterility. Supporting Customers Across Regulated Industries Operating.

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"Everything is going great with theservices. The technicians are top-notch - professional, honest, andvery solid in their work. They provide excellent communication and feedback."

Blake, REGENXBIO

Quantus-Autoclave-Sterilizer-Validation-Service
We Have Answers To Your Problems

Frequestly Asked Questions

What distinguishes Quantus’s cleanroom certification from other providers?

Quantus’s cleanroom certification process is distinguished by our precision, rapid scheduling, and the exceptional clarity of our reporting, which has been recognized by the FDA. We understand the unique demands of the 503A and 503B compounding pharmacies and offer certifications that not only meet but exceed the strictest of standards.

Our approach ensures minimal disruption to your operations, offering you a seamless certification experience that’s tailored to the specific needs of your facility.

How does Quantus ensure compliance with FDA regulations for compounding pharmacies?

At Quantus, compliance is at the core of our operations. We meticulously align our services with FDA guidelines and evolving industry standards to ensure that your compounding pharmacy remains compliant.

Our environmental monitoring and validation services are comprehensive, including detailed assessments that cover everything from microbial contamination to sterility testing, ensuring that your facility meets all necessary regulatory requirements for safety and efficacy.

Can Quantus help our facility prepare for the changing landscape of compounding pharmacy regulations?

Yes, Quantus is proactive in helping your facility adapt to the changing regulatory environment. Our team of experts is constantly updated on the latest regulations and industry best practices, which allows us to provide you with forward-thinking strategies and services.

From routine environmental monitoring to autoclave validation, we ensure that your operations are not just compliant today but are also equipped to meet future standards, safeguarding the continuity of your pharmacy's excellence.

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