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.

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