+38 066 4165366

+38 066 4165366

GMP

Good Manufacturing Practice (GMP) ensures consistence production process and product control in accordance with international quality standards.

GMP – is a global quality standard for the production of medicines, designed to reduce the risks of using any pharmaceutical product and is mandatory for all EU member states.

Compliance with GMP requirements is the best way to do business that put quality first.

GMP services

 Audit of pharmaceutical companies-manufacturers for compliance with the requirements of good manufacturing practice (GMP), conducting expert work and providing advice on good manufacturing practice (GMP);
 Audit of manufacturers of active pharmaceutical ingredients (API) for compliance with the requirements of good manufacturing practice (GMP);
 Corporate training of your company’s staff on GMP issues;
 Development of a corrective and preventive action plan (CAPA) to ensure compliance, as well as advisory support in the implementation of the CAPA plan.

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

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