We provide comprehensive consulting assistance and legal support in order to find solutions for problems that arise in the course of attaining market authorizations for medical products in Ukraine. Our specialists know everything about market launching for medical products and are ready to help our clients in word and in deed. We offer an overall range of consulting services, beginning with consultations and ending with execution of Authorized representative functions.
A thorough knowledge of all the nuances and the phases of the conformity assessment procedures, allows us to guarantee our customers maximum efficiency in the legalization of medicinal products on the Ukrainian market
Our company provides a full range of services of the Authorized Representative to manufacturers of medical products.
Working with your organization, we guarantee to achieve our goals by applying a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and management processes
The technical file is proof that the medical device meets the basic safety requirements that have been taken into account in the legislative acts. Our team will help you to create all the necessary documentation, taking into account all the necessary requirements
If you want to place medical products in the European Community Market, then you should rely on us
Using the services of a preclinical contract research organization, you will be able to benefit from specialized research models, expert advice and reliable data to present the product for regulatory approval and ultimately to the clinical market.
We support you with regard to the use of clinical data for your product approval or post-market strategy including collection, appraisal and analysys of clinical evaluations in Ukraine
Providing the widest possible range of services for Ukrainian and foreign manufacturers of Medical Products
Why is Regconsult worth choosing as your Authorized representative in Ukraine?
We offer consulting assistance and marketing services whilst preparing the market launch of new goods.
We organize the translation of documentation and necessary authorization procedures for passing during the course of the market launch for medical products in Ukraine.
We render logistics services and elaborate promotional strategies after the official implementation of goods for operation.
For every specific task we work out several variants for a solution with due account of material and technical expenses.
Our team consists of competent specialists in various fields of professional knowledge and skills: lawyers, marketing consultants, translators and interpreters, auditors, editors, managers – we work with the utmost efficiency and are dedicated to the result.
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