GMP Protein Analysis
GMP Compliant Biopharmaceutical Analysis
Quality is key to our business and is a fundamental pillar of the company's culture. Protagen AG has established a quality management system that oversees aspects of our processes.
Protagen AG is dedicated to providing the highest quality analytical services. Clients benefit from our:
- Excellent technical knowledge
- Long-standing experience
- Peer-review reports
Protagen AG operates its facility in accordance with Good Manufacturing Practice (GMP) as monitored and inspected by Bezirksregierung Arnsberg, Germany who have certified that Protagen AG may conduct testing according to Sect 14 para 4 No.3 of the German Drug Law (GDL) to perform quality testing on medicinal products for human use. This approval covers the testing procedures of protein analysis.
Certificate of GMP compliance 2010 (Section 14 para 4 No.3, German Drug Law (GDL), AMG))
Protagen AG offers a broad spectrum of qualified analytical equipment and validated methods. We have the expertise to develop and validate client specific methods.
Protagen AG has successfully introduced technology to the regulatory authorities and received excellent feedback for its quality system from frequent audits by its renowned clients.
Our experienced team offer a wide range of support including analytical method development, method validation, method transfer, stability testing and release testing on biopharmaceutical products.
Your contact for GMP Compliant Biopharmaceutical Analysis at Protagen AG
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Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |