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More information about our services is available below: Marketing authorization procedures Allopathic (original and generic medicinal products, WEU-, hybrid- informed consent- and second brand applications and traditional herbal medicines) and homeopathic medicinal products:
- filling in applications forms - translation of SmPC, PIL and labeling and re-translation of approved texts - providing complete administration and communication with the authority during the procedures - consultancy - dealing with line extension applications - administration of ancillary procedures related to marketing authorizations (switch to global numbering, withdrawal of a marketing authorization, formal differences from marketing authorization, change of classification, MAH transfer, new etc.) and providing consultancy Renewal Clinical trials Pharmacovigilance Variation Wholesale distribution Manufacture Paramedicines Parallel trade Promotion of medicines |
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