• Start-up: organizzation analysis and mapping, set-up of the services, training of the service Responsible Person and staff;
• Standard Operating Procedures: set-up / upgrading of the SOPs according to the italian and european requirements;
  
• training: on SOPs and/or on regulatory provisions for internal/external staff (RAPs, clinical investigators, CROs etc.) web based training;
• Auditing: performance of audits and operative supports for the implementation of corrective actions;
• Licensing agreement: initial analysis, procedures preparation/upgrading, auditing;
• PSURs: preparation and set up of the reports, follow-up and management of request from MrK Company to Mother Company;
• Project Management: design and management of work Projects;
• Process optimisation: Organizzation analysis and work proposals.

<--