Simultaneous work with 14 medicinal products, received 8 MA. - planning and registration of new medicinal products (MP) (CTD format); - re-registration of the MP; - preparation of variations to the Registration Dossier in accordance with the requirements of the Ministry of Healthcare; - supervision and control of the registration process until the receipt of the MA, including preparation of responses to the requests issued by the Russian Regulatory Authorities within the time limits established by the procedure; - preparation and submission of the Registration Dossier to the Ministry of Industry and Trade (Minpromtorg) for GMP inspections and GMP audit support; - introduction of changes to the registration prices; - preparation and submission of samples together with the relevant package of documentation for the pharmaceutical expertise; - preparation of Russian Instructions for Medical Use; - preparation of Russian SmPC based on the EU SmPC; - documentary expertise of the documents for clinical studies, preparation and submission of the documentation package for obtaining permission to carry out Clinical Studies; - preparation of layout designs in the Artwork program; - preparation of documents for import of the samples for pre-clinical studies/clinical studies/laboratory pharmaceutical expertise, customs procedures control; - preparation of PV documentation (CIOMS) for Roszdravnadzor; - control of financial documentation, agreements; - archiving of the documentation at the Registration Department.

Simultaneous work with more than 20 medicinal products. - preparation and submission of the Registration Dossier for medicinal products/API to the Ministry of Healthcare of the Russian Federation in accordance with the Federal Law No. 61 ‘On the circulation of medicinal products’ dated April 12, 2011; - preparation of variations to the ND in accordance with the requirements of the Ministry of Healthcare (MoH) and submission of variations to the MoH; - supervision and control of the registration process until the receipt of the MA, including preparation of responses to the requests issued by the Russian Regulatory Authorities within the time limits established by the procedure; - process control of the organization and execution of pre-clinical studies and bioequivalence testing; - translation of CoAs and brief Manufacturing Flow Charts from English into Russian; - preparation and submission of samples together with the relevant package of documentation for the pharmaceutical expertise; - coordination of the Registration & Logistics Department’s activity; - control of financial documentation; - archiving and proper accounting of the documentation at the Registration Department.

Simultaneous work with more than 20 medicinal products. - preparation and submission of the Registration Dossier for medicinal products/API to the Ministry of Healthcare of the Russian Federation in accordance with the Federal Law No. 61 ‘On the circulation of medicinal products’ dated April 12, 2011; - preparation of variations to the ND in accordance with the requirements of the Ministry of Healthcare (MoH) and submission of variations to the MoH; - supervision and control of the registration process until the receipt of the MA, including preparation of responses to the requests issued by the Russian Regulatory Authorities within the time limits established by the procedure; - process control of the organization and execution of pre-clinical studies and bioequivalence testing; - translation of CoAs and brief Manufacturing Flow Charts from English into Russian; - preparation and submission of samples together with the relevant package of documentation for the pharmaceutical expertise; - coordination of the Registration & Logistics Department’s activity; - control of financial documentation; - archiving and proper accounting of the documentation at the Registration Department.