Regenity

Regulatory Support

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Securing approvals can be challenging amid a shifting regulatory landscape. With a deep history in collagen-based products and polymer science, we support our clients through global regulatory submissions, claims development, as well as clinical study and protocol development consultations. With years of experience designing preclinical and clinical studies for regenerative devices, our team is well versed in the intricacies of obtaining regulatory approvals.

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As part of the regulatory process, many of our medtech clients leverage our cell biology lab in New Jersey to evaluate new materials on the bench to determine how cells behave and react. These crucial insights provide early indicators of product performance opportunities as well as data to support regulatory approvals.