- Preparation and submission of documentation for marketing authorization applications (full dossiers, generics, generic hybrid, well established use application) for human medicines (chemical medicines, biological medicines, biosimilars, herbal medicines, homeopathic medicines) and renewals
- Preparation and submission of variations (type IAin, IA, IB and II)
- Preparation and submission of documentation for changing the classification for the supply of a medicinal product for human use (including OTC switch)
- Review of CTD relative to active substance and final product and conforming it to requirements of national legislation (in Serbia, Montenegro, Bosnia and Herzegovina, Former Yugoslavian Republic of Macedonia)
- Preparation of documentation for MAH ownership transfers
- Scientific expert translation from English to Serbian of all required documentation for MA procedures of medicines, including edits of translated text (accuracy, national requirements, medicinal terminology)
- Assistance and monitoring of the authorization procedures at competent regulatory authorities till their successful completion
