- Founding year: 1985
- Owner-managed company
- Many years of experience
- Micronization and refining of your pharmaceutical products
- Processing of quantities from a few grams to tonnes
- Highest quality and safety standards
- Various certifications and approvals (GMP certificate, manufacturing authorization, FDA authorization, accreditation in Japan)
- Trained employees
- Global customers
cGMP describes guidelines for “good manufacturing practice”. The focus here is on the quality assurance of the production processes and production environment for the processing of pharmaceuticals, active agents and medical devices.
Quality management system (QM system)
We employ a QM system that includes the “good manufacturing practice” in accordance with our activities. All in-house divisions concerned with the creation, maintenance and implementation of the QM system are permanently subject to the requirements of the EU GMP guideline.
The Qualified Person checks the batch release and thus the formal and substantive accuracy of the batch documentation in accordance with the EU GMP guideline.
We are accredited in Japan as a certified manufacturer. In cooperation with our Japanese business agent, we will be happy to assist you to obtain accreditation for your products for the Japanese market as well.
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Our company has a manufacturing authorization in compliance with §13 AMG (German Medicinal Products Act). As such, our cGMP conformity is regularly confirmed by the responsible authorities.