With more than twenty years of experience, our team reviews your documents, conducts the necessary literature searches and prepares scientifically sound pharmacological-toxicological and clinical expert reports (Expert Reports) for your bibliographic marketing authorization application in CTD format in a short time.
We prepare pharmacological-toxicological and clinical expert reports for you according to § 24 para. 1 no. 2, 3 AMG, corresponding to CTD modules 2.4 and 2.5.

The following services can be ordered individually:

  • Drafting of clinical expert reports according to § 24 para. 1 no. 3 AMG in the context of national marketing authorization procedures.
  • Preparation of Clinical and non-clinical Expert Reports in accordance with the requirements of the "Notice to Applicants" in CTD format.
  • Preparation or updating of Pharm.-tox. and Clinical Expert Reports - also on phytopharmaceuticals - in accordance with § 24 Para. 1 No. 2,3 AMG within the framework of national marketing authorization procedures, marketing authorization extensions and post-authorization procedures including.
    ◦ Researching the literature on pharmacology, toxicology, and clinical aspects.
    ◦ Obtaining relevant original publications.
    ◦ Preparing the documentation


MIT Gesundheit GmbH
Thaerstraße 4a
47533 Kleve

Dr. J. K. Merges
Dr. F. J. Merges
O. J. Merges
E-Mail: info /*et*/ mit-gesundheit.com

Amtsgericht Kleve
Trade register no. 21 HR B 1459
UID-Nr.:DE 162 177 018
Authority Regierungspräsidium Düsseldorf


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