Exhibitor at CPhI Worldwide 2021 stand 2C73, ICSE General Floor
GRUPPO SASI is a company of software and services, modern and innovative, which since 2008 has successfully addressed pharmaceutical, chemical and medical device companies to face the various management problems that from time to time the market has placed in the priorities of management resolution.
Our main specialized applications have produced innovative solutions for the Pharmaceutical Industry relating to the design and the electronic submission of the Dossier of Registration of the Drug Product 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.
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 Directive 2010/84/EU amending Directive 2001/83/EC.
Also for the Medical Device sector, our proposal TechFile Manager fully complies with all the regulations required by the European Parliament Regulations 2017/745-2017/746.
Specs about this supplier
|Sales markets||Europe - EU countries|
|Affiliated categories:||Computer software |Regulatory Affairs |Technology and Software More|
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