Megainpharm GmbH

Marketing Authorization in the Russian Federation

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. Our comnpany has ample experience in the field of state registration of pharmaceutical products. Our specialists design the most effective projects of state registration for medicinal products, pharmaceutical substances and medical devices, that allows to complete the registration as soon as practicable without spending extra resources. Read more

Marketing Authorization in the EU

Obtaining MA in the EU is a complicated process requiring certain knowledge and expertise in both, scientific and regulatory fields. Megainpharm GmbH has vast experience in interacting with main European regulatory bodies and leading scientific research centers. We can assure high probability of positive outcome due to our sophisticated approach to challenges arising in the course of obtaining Marketing Authorization. Read more

Preclinical Trials of Medicinal Products

Megainpharm GmbH is experienced in preclinical trials management within the territory of Russia and the European Union. We cooperate with numerous scientific research centers in order to design the most effective preclinical trials plan complying with all existing laws, regulations and reference documents. Successful completion of preclinical trials results in clinical trials authorization for further studies of medicinal product safety and efficacy. Read more

Clinical Trials of Medicinal Products

Megainpharm GmbH is experienced in clinical trials management within the territory of Russia and the European Union. We cooperate with numerous licensed clinical centers in order to design the most effective clinical trials plan complying with target product profile, all existing laws, regulations and reference documents. Read more

Local Representative of MA Holder

Megainpharm GmbH has ample experience in the field of commercial release of medicinal products. Positioning of our headquarters in Vienna, Austria allows for easy cooperation with leading pharmaceutical distributors and pharmacy chains operating in the European Union. Thereby, we can offer our services as local representative of Marketing Authorization holder. Our team of experts design the most effective distribution plans, with respect to product’s specificities, existing laws and regulations and reference documents. Read more

Product Localization in CIS Countries

Megainpharm GmbH has ample experience in the field of medicinal products manufacturing process management in accordance with all existing laws and regulations on the territory of the Russian Federation. This experience allows us to provide services and consultation in production localization within CIS territory to our clients who plan to launch a production at that locale. Read more

EU cGMP Certification

Megainpharm GmbH core activities are tightly related to medicinal products production and distribution within the territory of Russia and the EU. These processes require confirmation of compliance with applicable standards in order to obtain appropriate certificates, including Marketing Authorization. Main standard requiring compliance certification is called Good Manufacturing Practice – GMP. Read more

About

Megainpharm GmbH founded in 2003 in Austria, is a long-term partner of the company LLC INFAMED involved in manufacturing and distribution of multiple application antiseptic solution Myramistin® on the territory of the Russian Federation and CIS countries. Currently, Megainpharm GmbH is managing the project for obtaining Marketing Authorization for commercial release of Myramistin® in European markets. Myramistin® has successfully passed preclinical trials, at the moment it is undergoing efficacy studies in patients diagnosed with acute pharyngitis and laryngitis. For the years of project management, our team has gained vast experience of strong cooperation with competent authorities and can offer support and services in registration of medicinal products in the European Union.

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CASES

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);... Подробнее

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... Подробнее

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... Подробнее

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