Tel. (+39) 0287065690 Mail Contacts Mail Assistance Customer Area Who we are Organization Market Products Where we are eCTD-Pharma Regulatory document management system. More info .. Events and News 6-8 / 06/2018 We are present at the 58th AFI Symposium 07/06/2017 MaDe presentation 7-9 / 06/2017 We are present at the 57th AFI Symposium Medical device Pharmaceuticals Chemicals SASI group srl is a modern and innovative software and services company, which since 2008 has been successfully targeting pharmaceutical, chemical and medical device companies to tackle the various management problems that the market has placed in management's priorities for resolution from time to time. Its professionals know how to move successfully in the management of organizational complexity with a high design competence gained in the field, sharing with their customers the creation of core-business applications, and ensuring them a very competitive cost-performance ratio. In fact, it manifests itself to its customers with a balanced approach that finds its roots in the good tradition of the IT profession and which incorporates those methodological sensibilities that over time the market has been able to propose to the attention of operators as real and effective opportunities to be seized. It has designed its own technological framework - - for the management of information content which is the basis of its entire product line and which is addressed to all those operational processes which by nature require careful management of their life cycle and as such they must be certified. Its architecture was designed with the aim of giving the customer specialized applications that have a superior structural value, a property typical of a standard product, but also capable of expressing the characteristic value of applications made to measure for an end user. Our main specialized applications have produced innovative solutions for the Pharmaceutical Industry relating to the design and electronic submission of the Drug Registration Dossier to the Regulatory Authority according to the organizational models defined by the CTD / eCTD standard. Similar important solutions have been developed for the Chemicals sector in the design of the Drug Master File for the production of active ingredients for the Pharmaceutical Industry in compliance with the Applicant Part / Restricted Part standard and for the CEP to be submitted to the EDQM. Another proposal for solutions in favor of the Pharmaceutical Industry is offered by the HosPurMan application(Hospital Purchase Management) equipped with functions designed in their broadest definition both as regards the procedural and operational aspects that govern the formulation of all types of tenders provided for by the legislation in force, and for the cognitive, managerial, managerial and administrative processes which originate from them and which are at the basis of the most sophisticated needs and expectations of the management structure of the companies that offer their products to the hospital sector. On the pharmacovigilance side, we propose the solution called PSMF Manager, for the management of the Pharmacovigilance System Master File, which is developed in full compliance with the legislation in force for the European community published on the European Medicines Agency website (www.ema.europa.eu) whose legal requirement was introduced by the 2010 directive / 84 / EU amending Directive 2001/83 / EC. Also for the Medical Device sector, our TechFile Manager proposal fully complies with all the regulations envisaged by the Regulations 2017 / 745-2017 / 746 of the European Parliament. eCTD Submission roadmap La eSubmission Roadmap si riferisce all'introduzione dello standard eCTD per tutte le tipologie di procedure secondo la tabella di marcia HMA e che, a livello Nazionale, diventerà obbligatorio per le nuove AIC a partire dal 1 Luglio 2018 mentre, per tutte le altre attività regolatorie, dal 1 Gennaio 2019. eSubmission Roadmap (visual representation) Annex 2 eCTD format for all submissions: 00 00 00 Mesi 00 00 00 Gio 00 00 00 Ore 00 00 00 Min 00 00 00 Sec Contattaci, abbiamo delle proposte per te. Contattaci I NOSTRI NUMERI 50 Aziende che utilizzano ns. eCTD-PHARMA 500 + Submission / Year with our eCTD-PHARMA 30 Companies that use our PSMF Manager 600 + Hospital competitions / Year with our Software Organization SASI Group since 2008 has been successfully offering solutions to pharmaceutical, chemical and medical device companies. More info » site map Information on .. Market Products Where we are Contacts (+39) 0287065690 contacts@grupposasi.com v. father reginaldo Giuliani 10 / A, Milan Italy Events and News 6-8 / 06/2018 We are present at the 58th AFI Symposium 07/06/2017 MaDe presentation 7-9 / 06/2017 We are present at the 57th AFI Symposium © Copyright 2017 GruppoSasi srl (Tax Code and VAT Number: 06287700964) - All rights reserved.