Regulatory Support

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Overview

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.

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.

To date, Regenity has secured:

  • Medical device approvals in 86 countries
  • 50 510(k) clearances
  • 23 CE certificates

Other Services

OEM Product Distribution

Our team offers customized product development as well as signature off-the-shelf products. If you’re looking to accelerate your pipeline, our pre-approved regenerative products are ready to roll…

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Product Development

From concept through commercialization, our dedicated cross-functional teams will work closely with you to bring novel ideas to market. With a proven history of producing more than 25 million medical…

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Contract Manufacturing

As your manufacturing partner, we offer state-of-the-art Class 10,000 (ISO Class 7) controlled environments. With a 19,000-square-foot clean room, 37,000-square-foot manufacturing area, and…

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Medical Grade Biomaterials

At Regenity Biosciences, we own end-to-end control of manufacturing logistics and proprietary processes to deliver collagen, our synthetic polymers and other biomaterials with unmatched purity,…

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Looking for a reliable partner to fill your product portfolio gap, co-create your next great innovation or manufacture your products?
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