Materials that make a difference
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.
We adhere strictly to all ICHQ7 guideline-based quality system, which form the basis of our processes and analytical methods.
This includes a certificate of analysis for every batch we produce, showing the analytical data determined in our quality control laboratory (with additional analytical data available on request).
We are ISO-9001: 2008 and ISO-14001: 2004 certified and all our polymers and monomers are covered with a Device Master File (MAF 1346) and a Drug Master File (DMF 21817) filed at the FDA.
Most importantly, we allow customers to see this for themselves: They audit our facilities on a regular basis.
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Society for Biomaterials Annual Meeting
Minneapolis, USA |
Stuttgart, Germany |