Regenity services

As your manufacturing partner, we offer state-of-the-art Class 10,000 (ISO Class 7) controlled environments. With more than 70,000 square foot of total manufacturing space between US + EU-based facilities (includes 20,000 square feet of clean room space), and established compliance and regulatory certifications mean we are able to scale up immediately.

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 out in as little as 12-16 weeks. Packaging, testing, sterilization, and global regulatory approvals are already in place. From there we supply the training and marketing content to support your success.

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 devices, Regenity offers highly customized solutions to extend your product portfolio. Our expertise optimizing cellular response has enabled us to help our clients launch breakthrough medical and dental products.

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.

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, quality, consistency, and versatility.