GXP- services of an authorized representative of the manufacturer of medical devices, medical devices for in vitro diagnostics, active medical devices that implant – GXP – services of an authorized representative of the manufacturer of medical devices, medical devices for in vitro diagnostics, active medical devices that implant

+38 066 4165366

GXP – expert agency

We provide professional consulting services for medical devices, in vitro diagnostic medical devices and active implantable medical devices

GXP is a competent and reliable regulatory partner for success of your company on the Ukrainian market of medical devices.

Why GXP?

We operate with a reliable information only.
We provide services on the highest level.
We involve the most competent advisors.
We work on the bases of effective law only
We work with reliable companies only.
We constantly learn and develop.

Why GXP?

We are a team of experts with a broad experience of work in medical devices regulation. We irreproachably know requirements of national and European legislation.
We provide services on a turnkey basis

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

+38 066 4165366

ar@gxp.farm