we make healthcare affordable
your no.1 partner for bioprocessing, batch release and GMP services
GMP quality management by proven specialists
You can rely on us. Since 2016, we have been specializing in quality consulting projects all over the world. With over 150,000 hours of experience in quality management-associated projects, we consistently achieve optimal results in fulfilling your duties. Our expertise lies specifically in Biosimilars and personalized medicine, where we utilize validated digital tools and demonstrate a remarkable passion for our profession. The distinct difference we bring to the table is something you can truly feel.
We have developed our own software applications, METIS for data management and TEMIS for document management, to fulfill the stringent requirements set by authorities. With our qualified personnel, we possess the capability to release batches with confidence. Additionally, our global team of freelancers enhances our capabilities and enables us to scale up the number of projects in a matter of weeks.
As a GMP quality management firm, we understand the criticality of precision and attention to detail in every aspect of our work. With our extensive experience, specialized expertise, and innovative tools, we are confident in our ability to support and guide you through the complex world of quality management.
Please let us know how we can assist you further.
Your benefits of QA outsourcing
1. Compliance expertise: Outsourcing to a specialized provider ensures access to professionals well-versed in regulatory requirements and industry best practices. This ensures improved compliance and reduces the risk of regulatory issues.
2. Cost savings: By outsourcing the GMP quality department, the company can avoid significant investments in infrastructure, training, and ongoing operational costs associated with an in-house quality team. This results in significant cost savings.
3. Focus on core activities: Outsourcing quality functions allows the company to concentrate on core activities such as research, development, and commercialization. By leaving quality management to experts, operational efficiency is enhanced.
4. Scalability: Outsourcing provides flexibility to scale the GMP quality department based on the company's needs. This allows seamless adjustments to changing production volumes, project requirements, or regulatory demands.
5. Risk mitigation: Utilizing an external GMP quality provider helps mitigate risks related to product quality, safety, and compliance. Experienced providers have established processes and systems to ensure adherence to GMP standards.
6. Time savings: By outsourcing the GMP quality department, the company can save time on recruiting, training, and managing a quality team. This allows internal resources to be allocated more effectively to strategic initiatives and core business activities.
Digital Twins
First-in-clas Digital Twin for CHO and HEK cells The technology can be used to determine and predict all cell culture parameters.
METIS
We develope EXCEL based applications for your GxP environment. Learn more about METIS our data historian for data management.
TEMIS
TEMIS is cGMP-compliant, adhering to the governing standards by FDA and EMA amongst others
GMP Service
To release your product for clinical use or commercial production, we offer the required batch certification for your medicinial products.
Philipp Hahn, CEO
As CEO, Philipp brings 25 years of experience in global corporations to kamosys. With a background in Chemistry and Molecular Biology, he has excelled in roles such as marketing, product management, and sales management. At Kamosys, Philipp's main responsibility is to lead a GMP compliant quality team and ensure the company is fully prepared to bring their incredible products to market.
Monika Brazda, Head of Compliance
Monika, a Biotechnology master's degree holder, has over 25 years of experience as a GMP expert in various companies. She is a Co-founder of QBDC and Kamosys and oversees the design and optimization of our quality systems. Monika's vision is to boost GMP compliance and enhance the overall quality of products and workflows in the whole (bio)pharmaceutical industry.
Karlheinz Landauer, Head of Production
Karlheinz, a biotech specialist with a PhD in Biotechnology, has 25 years of experience in animal cell culture and process development. He founded QBDC in Switzerland in 2016 and is passionate about quality management, upstream process development, and GMP development. As the second Co-founder of Kamosys, he focuses on designing production pipelines and incorporating epigenetic data into bioprocessing projects.
Alexander Morokutti-Kurz, Director Quality & QP
Alexander has a PhD in Applied Virology & Biotechnology and a background in Technical Chemistry & Biotechnology. He's worked as Head of QC departments and senior consultant before becoming our Qualified Person & Director of Quality Management. With his expertise, he handles audits, batch releases, and establishes/improves our pharmaceutical QMS. He's a valuable asset to our company, driven by his passion to cure health threats.
Contact us about anything related to our company or services.
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- Kamosys GmbH
- 7343 Neutal, Theodor Kery Strasse 55
- +43 676 5345614
- office@kamosys.eu
