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Medicinal Products for Human Use

For the registration of your pharmaceutical products, ibacon provides a wide range of laboratory and field studies which are carried out fully GLP-compliant. We are supporting you to meet the data requirements all over the world, in the EU, the United States, Japan, Australia, Brazil etc. All of our studies are performed based on the recent guidelines, guidance documents or literature.

At ibacon, we offer you

  • a broad spectrum of study types that are required for the registration of pharmaceutical products
  • 20 years of expertise in the conduction of GLP studies
  • the knowledge to deal with difficult substances
  • studies according to recent national and international guidelines, guidance documents and literature (e.g. OECD, ISO, OCSPP, JMAFF, EPPO, IOBC, SANCO and SETAC)
  • a state-of-the-art testing facility including 14C-laboratory
  • tailor-made study designs

 

You want to register a human pharmaceutical product?

You are uncertain which studies are required for your registration purpose?

We will assist you! Please contact Sabrina Westphal for more information.