Your contract laboratory for pharmaceutical analytics
Tentamus Pharma & Med Deutschland GmbH’s laboratories are equipped to handle the analytical tasks stipulated by pharmaceutical and medical device regulations.
Together with our clients, we tailor the chosen testing methods precisely and efficiently to the relevant requirements and regulations and document the analyses reliably and in compliance with regulatory rules. If required, we also develop and validate individual testing methods.
We update and continuously enhance our quality management systems. In addition, we participate in round robin tests and inter-laboratory comparisons in order to prove our analytical quality.
As a contract laboratory, it is extremely important to us to work in partnership with our clients and to communicate precisely and transparently.
Certifications, registrations and authorisations
- Our laboratories are GMP-certified for medicinal products for human use and veterinary pharmaceutical products.
- In Bad Kissingen, we hold a manufacturing licence in accordance with Art. 88 of Regulation (EU) 2019/6 and Section 28(1) of the German Medicines Act (TAMG) (→), which enables our Qualified Persons to monitor pharmaceuticals testing and release products.
- In Oldenburg, we hold a manufacturing licence in accordance with Section 13 of the German Drugs Act (AMG) (→), which enables our Qualified Persons to monitor pharmaceuticals testing and release products.
- We are registered with the FDA.
- Our microbiological laboratory is authorised to handle biosafety level 2 microorganisms (human and animal pathogens as defined by the German Infection Protection Act (Infektionschutzgesetz) and the German Animal Health Act (Tiergesundheitsgesetz)) and biosafety level I GMOs.
- We have a licence from the Federal Opium Agency of the German Federal Institute for Drugs and Medical Devices (BfArM) to handle various narcotic drugs.
- We offer batch certification and EU retests as by our Qualified Persons.
We are part of the
Tentamus Group
The Tentamus Group is a global network of highly specialised laboratories that ensure the quality and safety of essential everyday products from the areas of agriculture, food, pharmaceuticals and medical devices.