Certifications, registrations and authorisations

We perform high-quality labo­ra­tory analysis and deliver valid results – from routine analysis to customised bioassays.
  • 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.

Find your laboratory
We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
Privacy Settings
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Essential
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year