GXP is a competent and reliable regulatory partner for success of your company on the Ukrainian market of medical devices.
GXP is a reliable regulatory partner for success of your company on the Ukrainian market of medical devices.
We provide consulting services concerning medical devices and service of an Authorized representative for manufacturers non-residents of Ukraine. We will make a legal path to the Ukrainian 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 is to facilitate the process of legalization of medical devices for manufacturers non-residents of Ukraine and to create a legal way for new players to enter Ukrainian market of medical devices, that leads to a major breakthrough on the market in whole, protects customers’ and manufacturers’ rights
Our competence
We are a team of experts with a broad experience of work in medical devices regulation. We know irreproachably requirements of national and European legislation. We constantly learn and develop. We monitor changes in legislation. We involve advisors from expert centers, if necessary. We deal with accredited laboratories and conformity assessment bodies We audit companies when choosing a subcontracting service provider.
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GXP – YOUR AUTHORIZED REPRESENTATIVE IN UKRAINE
- Medical devices classification
- Conformity assessment support
- Professional assistance in the process of placing on the market class I medical devices
- Project support from development of medical devices to placing them on the market
- Execution of technical documentation
- Execution of a Declaration of conformity
- Consulting services concerning labeling of medical devices
- DSTU EN ISO 13485:2018 (development of QMS, implementation, certification support)
- Custom-made medical devices (application submission to the State Service of Ukraine on Medicines and Drugs Control support)
- Obtaining a permit from the State Service of Ukraine on Medicines and Drugs Control for realization of clinical investigations
- Authorized representative for manufacturers non-residents of Ukraine
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