Currently I’m in charge for all the chemical, pharmaceutical and microbiological (CMC) aspects of international registration documentation (pre- and post- approval activities) of three drug products and related APIs (iodine and gadolinium-based molecules).In my current position I guarantee, with respect to company objectives and timelines required by collaborating with other functions, either internal (company functions or subsidiaries part of Bracco group) or external, the preparation of filing dossiers (CTD Module 2-3/CMC for EU, US and/or other countries as appropriate) in compliance with current pharmaceutical legislation, for their submission to competent regulatory authorities (EU and US mainly) as necessary to the registration of new or already-marketed drugs.The assembly of chemico-pharmaceutical part of filing dossier relates to: New Drug Applications (NDAs), Supplements to NDA (SNDAs), Investigational New Drug Applications (INDs), IND Amendments, Annual Reports, EU/ROW Marketing Authorisation Applications (full, abridged or as appropriate), EU/ROW variations (type IA/IB, type II or as appropriate).I’m presently involved as regulatory Team Expert in projects focused on post-approval maintenance of drug products and/or related APIs (iodine and gadolinium-based molecules).

Currently I’m in charge for all the chemical, pharmaceutical and microbiological (CMC) aspects of international registration documentation (pre- and post- approval activities) of three drug products and related APIs (iodine and gadolinium-based molecules).In my current position I guarantee, with respect to company objectives and timelines required by collaborating with other functions, either internal (company functions or subsidiaries part of Bracco group) or external, the preparation of filing dossiers (CTD Module 2-3/CMC for EU, US and/or other countries as appropriate) in compliance with current pharmaceutical legislation, for their submission to competent regulatory authorities (EU and US mainly) as necessary to the registration of new or already-marketed drugs.The assembly of chemico-pharmaceutical part of filing dossier relates to: New Drug Applications (NDAs), Supplements to NDA (SNDAs), Investigational New Drug Applications (INDs), IND Amendments, Annual Reports, EU/ROW Marketing Authorisation Applications (full, abridged or as appropriate), EU/ROW variations (type IA/IB, type II or as appropriate).I’m presently involved as regulatory Team Expert in projects focused on post-approval maintenance of drug products and/or related APIs (iodine and gadolinium-based molecules).

Currently I’m in charge for all the chemical, pharmaceutical and microbiological (CMC) aspects of international registration documentation (pre- and post- approval activities) of three drug products and related APIs (iodine and gadolinium-based molecules).In my current position I guarantee, with respect to company objectives and timelines required by collaborating with other functions, either internal (company functions or subsidiaries part of Bracco group) or external, the preparation of filing dossiers (CTD Module 2-3/CMC for EU, US and/or other countries as appropriate) in compliance with current pharmaceutical legislation, for their submission to competent regulatory authorities (EU and US mainly) as necessary to the registration of new or already-marketed drugs.The assembly of chemico-pharmaceutical part of filing dossier relates to: New Drug Applications (NDAs), Supplements to NDA (SNDAs), Investigational New Drug Applications (INDs), IND Amendments, Annual Reports, EU/ROW Marketing Authorisation Applications (full, abridged or as appropriate), EU/ROW variations (type IA/IB, type II or as appropriate).I’m presently involved as regulatory Team Expert in projects focused on post-approval maintenance of drug products and/or related APIs (iodine and gadolinium-based molecules).