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About us
GXP is a competent and reliable regulatory partner to ensure a success of your company on the European Union and the Commonwealth of Independent States medical device market
GXP is a competent and reliable regulatory partner to ensure a success of your company on the European Union and the Commonwealth of Independent States medical device market
We provide consulting services on certification and marketing of medical devices (MD), in vitro diagnostic medical devices (IVD) and service of an Authorized representative for manufacturers non-residents in the EU We will make a legal path to the European Union and the Commonwealth of Independent States market of medical devices for your business We will become a part of your team and will act on your behalf according to the current law Our reputation works for you
GXP’s mission – to facilitate the process of medical devices legalization and to create a legal way for new players to enter the European Union and the Commonwealth of Independent States market of medical devices, which in general will lead to qualitative changes in the market.
Our competence
We are a team of experts with a broad experience in medical devices (MD) regulation (MD), good manufacturing practice (GMP), good distribution practice (GDP). We know irreproachably requirements of the national and European legislation. We constantly learn and develop. We monitor changes in legislation We involve advisors from expert centers, if necessary. We cooperate with accredited laboratories and notified bodies. We audit potential subcontracting service providers before we start our cooperation.
GXP by numbers
GXP’s mission – to facilitate the process of medical devices legalization and to create a legal way for new players to enter the EU and CIS market of medical devices, which in general will lead to qualitative changes in the market.
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CONTACTS
ul.Lubicz 27/40, 31-503
Krakow, Poland
+48 1225 44 831
+48 6906 25 630
info@gxp-europe.com
Our competence
We are a team of experts with a broad experience in medical devices (MD) regulation (MD), good manufacturing practice (GMP), good distribution practice (GDP). We know irreproachably requirements of the national and European legislation.
CONTACTS
ul.Lubicz 27/40, 31-503
Krakow, Poland
+48 1225 44 831
+48 6906 25 630
info@gxp-europe.com