Registration and regulatory support

Registration of medical devices and pharmacological drugs in the Republic of Kazakhstan and Ukraine

In the field of medical devices we offer the following services

- Consultation on registration/re-registration procedures and amendments to the registration dossier

- Formation of a registration dossier

- Support of the examination procedure during state registration/re-registration and amendments to the registration dossier

- Interaction with testing centers, registration and authorized bodies

- Support in assessing production conditions

- Assistance in obtaining an official letter confirming that the product belongs to the state registration of medical devices and consulting requests

- Conformity assessment of medical devices,

- Supporting audits at manufacturers production sites

In the field of pharmaceuticals we offer the following services:

- Development of a global registration strategy

- Registration/re-registration of medicines

- Making changes to registration documents of medicines

- GMP confirmation

- Providing a responsible person for pharmacovigilance

- Information support regarding new laws and regulations

- Constant monitoring of all sources of information

- Conducting investigations into adverse reactions

- Preparing and conducting audits and inspections

Do you need advise by registration or regulatory support? - - Contact