Phelonex empowers organizations with trusted consulting in compliance, quality, and technology.
From regulatory services to digital transformation, we deliver results that move business forward.

Our Core Domains

Life Sciences

Phelonex is a specialized in supporting medical device and IVD manufacturers in navigating the complexities of global regulatory compliance. We combine deep industry expertise with practical, hands-on support to help companies bring innovative, safe, and effective products to market.

Our team has extensive experience in quality systems, regulatory submissions, and technical documentation aligned with standards like ISO 13485, EU MDR/IVDR, and FDA requirements. As a responsive and trusted partner, we help reduce risk, streamline compliance, and accelerate your path to market success.

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Technology

At Phelonex, we help organizations unlock the full potential of technology through tailored digital solutions and expert consulting. Whether you're modernizing infrastructure, implementing cloud platforms, or validating AI systems, we bring the knowledge and precision to ensure seamless execution. Our team specializes in Salesforce, AWS, GCP, and AI testing—empowering you to innovate confidently, scale efficiently, and stay ahead in a rapidly evolving digital landscape.

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Hours

Monday – Friday
9am – 5pm EST

Phelonex

971 Us Highway 202n Ste N, Branchburg, Somerset County, NJ 08876 US

info@phelonex.com
+1(973) 291-5525