Pharma

  • Development of pre-registrative strategy plans and regulatory/technical-scientific framework, through the definition and the management of clinical development programs
  • Feasibility analysis relating to projects of strategic interest for the Company, through the deepening of the existing legislation and guidelines, the analysis of the reference framework and the regulatory conditions for the specific medicinal product category, in order to identify the best strategy for the finalization of corporate objectives with time and cost optimization
  • Support in the Scientific Advice request with the relevant Competent Authority: from documents preparation to the procedure management, including meeting attendance
  • Power of Attorney to act on behalf of the Company with the National Competent Authority, also for foreign Companies
  • Support for a new Company start-up activities: SIS Code request, registration on AIFA database (Fee Portal e AIFA Front End)
  • Support in national and Community registrations of medicinal products for human use, through:
    • Registration dossier preparation (modules 1-5) in CTD format, e-CTD, Nees, conformity opinion for the check-in phase;
    • Procedure management and contact point with the National Competent Authorities, preparation of response documents during the assessment phase, support up to the obtaining the Marketing Authorization;
    • Preparation of national Product Information.
  • Support in medicinal products maintenance activities, such as:
    • Preparation of quality, pre-clinical and clinical overview, Modules 3, 4 and 5 in support of quality or safety variation applications, Marketing Authorization renewals and line extensions;
    • Evaluation, preparation, filing and follow-up of administrative, quality or safety variation applications, line-extension, Marketing Authorization renewals;
    • Reformatting of dossier in CTD format, e-CTD, Nees.
  • Due diligence: regulatory documentation review, in order to highlight any scientific, technical and documentary issue, with the scope to support and optimize the company strategies on the products portfolio
  • Gap-analysis in order to align “obsolete” dossier to existing regulatory requirements (EU and ICH)
  • Support in setting up the dossier for the registration of medicines in Extra-EU countries
  • Product Information editing and translation
  • Regulatory support in accordance with article 14 of Legislative Decree no. 283 of May 29, 2001: legislation on bilingualism
  • Support to pharmaceutical Companies for the fulfillment of Farmastampati communication in compliance to AIFA Decision dated April 14 th 2014
  • Readability tests of Patient Information leaflets for medicinal products for human use: support to pharmaceutical Companies for the preparation of Module 1.3.4 of new Marketing Authorization registration dossier
  • Ministry of Health procedure management related to narcotic drugs and psychotropic substances authorizations
  • Assessment of regulatory compliance of medical and scientific information materials
Activities related to manufacturing sites:
  • Support in Authorization/registration/importation/extension applications
  • Support in GMP certificates applications
  • Qualified Person applications (addition, change)
  • Narcotic and psychotropic substances
  • Follow-up during procedures
  • Free Sale Certificate applications and legalization
  • Certificate of Pharmaceutical Product (CPP): application to AIFA, certified translation, endorsement at Consulate