| Expert reports on "Quality",
"Efficacy" and "Safety" of herbal medicinal
products and chemical-synthetic remedies according to the format
of the "Common Technical Documents" (CTD) |
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| Expert reports (clinical and nonclinical)
for the marketing authorisation of herbal medicinal products
according to the procedure of "traditional use" (Directive
2004/24/EC) and "well established medicinal use" (Directive
2001/83/EC) |
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| Expert opinions and documentation for
the registration of homeopathic remedies according to §
38 AMG und 2001/83/EC |
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| Replies to letters of complaints of regulatory
authorities |
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| Periodic Safety Update Reports (PSUR) |
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| Second opinions according §105 AMG |
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| Delimitation and classification of medicinal
products / food supplements / food / cosmetics / medicinal products.
Advice for the use of herbal medicinal plants in cosmetics |
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| Studies on phytoequivalence and dissolution
of herbal medicinal products (also experimental) / characterisation
of herbal extracts (also experimental) / registration of herbal
medicinal products in Switzerland / European Pharmacopoea |
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| Planning and evaluation of pharmacological,
toxicological and clinical projects (observational studies and
GCP conform trials) including preparation of course schemes,
investigational medicinal product dossiers (IMPDs) and Integrated
Clinical Trial Reports (ICTRs) |
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| GLP-certified analysis of hepatotoxicity
and liver cell metabolism in liver cell cultures of human and
rodents |
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| Analytical investigations
of herbal medicinal products using state-of-the-art analytical
equipment (HPLC-MS/MS, GC-MS, HPLC-UV and fluorescence) |
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Biopharmaceutical analysis of herbal active agents from plasma,
urine, tissue with HPLC-MS/MS; GC-MS, HPLC-UV, HPLC-fluorescence;
method development and application
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| Risk evaluation for cosmetics |
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| Systematic reviews on quality, efficacy
and safety of medicinal drugs according to the criteria of "evidence
based medicine" |
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| Literature research in the areas of human
medicine, pharmacology, toxicology and pharmacovigilance |
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| Research, analysis and assessment of adverse
reactions |
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| Publication service (e.g., reviews and
abstracts) |
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| Certified and individual
advanced training courses for physicians / pharmacists and other
professionals (accredited by medical associacions) /botanical
exkursions / press conferences |
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| Botanical expert reports (desk and field
research) on botanical identity, ecology, sustainability, and
bio-prospecting |
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| Evaluation of species and nature conservation
aspects in agriculture, domestication of wild species, organization
of contract cultivations, GAP-audits and training, documentation
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| Selection and characterisation of plant
varieties according to specific requirements |
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| Dossiers for (new) botanicals, organization
of sourcing and traceability projects |
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| Preparation of GMP audits |
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| Development of herbal extracts |
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