Megainpharm GmbH core activity is state registration (Marketing Authorization) of pharmaceutical products intended for medical use, i.e. medicinal products, medical devices and pharmaceutical substances within the territory of the Russian Federation and the Eurasian Economic Union (Belarus, Kazakhstan, Kirgizia, Armenia).

Example of Russian Product Registration in Europe

Russian manufacturers of medicinal products face numerous challenges trying to achieve this goal. Roughly, all these challenges can be classified into two types: obtaining importing license (in case of exporting goods from the existing production in the EEU and not CMO in the EU); obtaining product registration – Marketing Authorization.

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Example of the EU Product Registration in the EEU Countries

Due to the fact that our company has direct access to the EEU countries through our long-term partner LLC INFAMED, we have already assisted few European producers to enter the Russian market with their finished pharmaceutical forms and medical devices.

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Contract Manufacturing Organization and Production Localization

We are ready to share our experience in understanding of production sites arrangements in the EU with colleagues from the EEU countries who consider contract manufacturing. Solid formulations, semi-solid formulations and liquids require specific knowledge and understanding of local producers’ production capacities. We apply our and our European colleagues’ experience to select a partner (CMO) for localization of your product in the EU.

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