About us:

Bureau “Cratia” is a private independent professional outsourcing agency that assists foreign and local companies in state registration of their products in Ukraine. Medicinal affairs are our main business, but we also provide services of clinical studies phases’ I-IV and market research studies upon request.  
Registration (re-registration) of Rx and OTC medicinal products, medical devices, supplements, nutrition and substances is performed by greatly experienced team that consists from doctors, chemists (analytics), technologists and negotiators. Every our team expert has a many years of practical experience that allows us to achieve great success as in dossier preparation process, as in communication with state authorities.

Structure:
I. Regulatory affairs department: 

Sub department of drugs (medicinal products) and substances (API’s).
Main State authority: State Pharmacological Center of Ukraine.
Responsibilities: assistance in marketing authorization of medicinal products and substances in Ukraine, renewal of it and implementing changes to the registration certificate, adoption of the clinical studies. 

Sub department of medical devices and immunobiological products.
Main State authority: State Authority of medicinal products and medical devices.
Responsibilities: assistance in marketing authorization of medical devices and immunobiological products in Ukraine, renewal of it and implementing changes to the registration certificate, confession (recognition) of GMP.

Sub department of bio-active (dietary) supplements.
Main State authority: State sanitary-epidemiologic authority.
Responsibilities: assistance in marketing authorization of bio active supplements, special food products, nutrition products in Ukraine, renewal of it and implementing changes to the registration certificate.

II. Administrative department:
Administrative group is mainly engaged in process management, customer service relations and law assistance of the regulatory affairs department. Department is also plays the role of the bridge between Customer and executives from regulatory department.

For business development please contact Mr. Dmitry Kulikov (dmitry.kulikov@bureaucracy.com.ua).