Pharma sector consultancy
Studio tau activity in the regulated fields also includes also the most critical one, the pharmaceutical sector .
Studio Tau professionals have always operated in this sector and – during the time – they developed an extended capability to support companies’ needs, both technical and regulatory.
Our pharma sector consultancy is addressed to:
– access to EU market for a drug (*);
– achievement of FDA clearance to export toward USA
supporting the company in the different phases of these processes.
The first goal is product effectivness, which must be demonstrated according to the specific protocols; besides this it is essential to have a stituation where:
– the processes are regulated according to GMP
– if they are atutomated they meet GAMP criteria
– distribution is organized according GDP.
GMPs set up the bases for most advanced topics such as:
– Forced Degradation Studies
– Data integrity – Data management
– Sterility Assurance – Comparison technologies. Isolators and restricted access barriers (RABS)
– Qualification, Process Validation, Cleaning Validation i nthe mew approach of Eueopean GMP and FDA
Whichever your need, Studio tau is ready to support you for both the product and the system; also we develop systems taking care of both GMP and ISO 13485 requirements.
(*) in Italy “Autorizzazione Immissione in Commercio”
in Switzerland “Omologazione e messa in circolazione di medicamenti per uso umano”