Marketing Authorization in the EU

Регистрация лекарств в ЕС 

   You can rely on our practical knowledge in European and international regulatory fields at all stages of obtaining Marketing Authorization for pharmaceutical products in Europe. We have a vast experience in designing projects that comply with all applicable requirements. Our experts select the most effective way of research and development of your product, starting from recommendations on bioanalysis and preliminary meetings with EMA and other competent authorities, to obtaining Marketing Authorization by assuring sufficient support on compliance with regulatory requirements. Obtaining MA in the EU is a complicated and time-consuming process requiring certain knowledge and expertise in both, scientific and regulatory fields. Our company has vast experience in interacting with main European regulatory bodies and leading scientific research centers, that allows to design the most effective project of a product development and registration with respect to its specifications and potential risks.

We can assure high probability of positive outcome due to our sophisticated approach to challenges arising in the course of obtaining Marketing Authorization. Megainpharm GmbH offers a variety of services and support in registration of pharmaceutical products in the EU, starting from support with interacting with competent authorities to suggestions on pharmacovigilance system at the stage of commercial release.

We thoroughly trace any changes in regulatory requirements as they are implemented in order to adjust our projects swiftly and effectively. Our proactive approach and timely support preclude the exposure of unexpected and adverse issues. We timely communicate the changes with all the parties involved in the project, which significantly improves the overall performance. We apply our experience to the management of scientific knowledge and documentation, manufacture, monitoring system, obtaining approval for protocol drafts from EMA, ethics committee and other regulatory bodies.

Регистрация лекарств в ЕС 

Megainpharm GmbH offers the expertise in the following fields:

  • local regulatory requirements;
  • transition from researching to practical activities;
  • feasibility studies of accelerated procedure of registration;
  • obtaining approval for clinical trials;
  • interacting with competent authorities.

Our office is located in Vienna, heart of Europe, which makes it effective to cooperate with competent authorities and easily arrange international meetings.