About Mycoscience Labs

Dedicated to Excellence

Since 1990, Mycoscience Labs has provided the scientific medical community with quality laboratory and consulting services. Our professional staff specializes in the research, evaluation and qualification of medical products regulated by the U.S. Food and Drug Administration. This expertise with FDA regulations combined with extensive laboratory skills enables us to navigate your products smoothly through tumultuous regulatory waters. We plot a comprehensive yet economical course for your products from conception stages through manufacturing. Our facility is FDA registered in addition to being ISO 13485:2016 certified.

A World of Experience

When it comes to meeting medical device, pharmaceutical, and in-vitro diagnostic regulations we have a world of experience, not only with FDA standards but with EN and ISO requirements as well. Visit our modern facility conveniently located along the I-84 corridor between Boston and New York and meet our dedicated professionals. We have the training, experience, and quality standards you require, and we deliver the level of service you deserve.