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In support of implantable technologies as diverse as cardiovascular devices, orthopedic implants, tissue regeneration scaffolds, and wound management systems, we offer you a proven family of resorbable polymers – supported by years of expertise across everything from contract manufacturing to custom synthesis.
When it comes to biomedical and resorbable polymers, our track record stretches back to the 1960s.
Today, our state-of-the-art GMP production, research and QA/QC facilities make us one of the most reliable large-scale (yet independent) partners to the industry.
Our PURASORB® family of resorbable polymers can be produced in batch sizes of 5kg up to over 100kg – across a broad range of different specifications. Our R&D laboratory includes a 2kg scale pilot facility, as well as a variety of equipment dedicated to the development and support of polymer compositions.
But our expertise isn’t limited to manufacturing: We also provide extended analytical services and analytical method development and validation.
Quality Resorbable Polymers for Medical Implant Devices and Controlled Drug Delivery Formulations
We maintain cGMP quality systems compliant with ICHQ7 as the basis of our processes and analytical methods.
A Certificate of Analysis is provided with every batch we produce, showing the analytical data determined in our quality control laboratory (with additional analytical data available on request).
We have ISO-9001:2015 certified, dedicated manufacturing facilities in the U.S. and the Netherlands. All our polymers and monomers are covered with a Device Master File (MAF 1961) and/or Drug Master Files (DMF 21817) & (DMF 31084) filed with the FDA.
Most importantly, we allow customers to see this for themselves: They audit our facilities on a regular basis.
We adhere to ICHQ7 guidelines and our processes and analytical methods are validated accordingly
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