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. Production localization in Russia and CIS is a state-controlled process, that requires knowledge of national regulatory specificities and experience in cooperation with competent authorities in order to raise the prospects of obtaining appropriate authorizations and avoid controversies with legal bodies during cooperation. Nevertheless, there is particular demand for localization of foreign medicinal products in Russia and CIS countries, due to their high quality and new technologies. Our expert team design the most effective development and localization plans for medicinal products with respect to specificities of the product and client’s preferences, starting from preliminary meetings with competent authorities to site construction supervision or signing a contract with a contract manufacturing organization. Megainpharm GmbH thoroughly trace any changes in regulatory requirements as they are implemented, and always find creative solutions for adjusting localization process to new standards. Our team of professionals timely communicate the changes with all the parties involved in the project, and is committed to implementing the project within defined timelines without spending extra resources.

We offer the following services in the field of production localization: