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Pharmacotoxicological and Clinical Reports / Expert Reports / PSUR |
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With more than twenty years’ experience, our team reviews your documents, carries out the necessary literature searches and compiles scientifically sound pharmacological/toxicological and clinical reports in CTD format within a short timeframe for your bibliographical submission.
We can write your pharmacological/toxicological and clinical reports for you as laid down in § 24 paragraph 1, subparagraphs 2, 3 of the German Medicines Act (AMG), in conformity with CTD modules 2.4, 2.5 etc.
You can call up the following services individually:
- Writing of pharmacological/toxicological reports in CTD format as laid down in § 24 paragraph 1, subparagraph 2 of the AMG in the framework of national regulatory approval procedures.
- Writing of clinical reports in CTD format as laid down in § 24 paragraph 1, subparagraph 3 of the AMG in the framework of national regulatory approval procedures.
- Drafting of Expert Reports in CTD format in the framework of EU-wide regulatory approval procedures as specified in the "Notice to Applicants".
- Updating of pharmacotoxicological and clinical reports - including phytopharmaceuticals – in the framework of re-submission procedures, including
- Pharmacological, toxicological and clinical literature searches
- Procurement of relevant original publications
- Preparation of documents
- Periodic Safety Update Report (PSUR)
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Pharmaco-tox. Expert Reports
