Contract Manufacturing
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 comprehensive manufacturing services include:
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Process development and validation
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Packaging design and validation
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Sterilization validation
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Shipping simulation studies
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Environmental storage studies
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Shelf-life studies
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Labeling
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Storage
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Distribution
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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Regulatory Support
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…
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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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