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.

Legalization of Medical Products

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

Ukrainian Authorized Representative

Our company provides a full range of services of the Authorized Representative to manufacturers of medical products.

Internal audit service (IAS)

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

Creating Product Documentation

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 

EU Authorized Representative or CEpartner4U

If you want to place medical products in the European Community Market, then you should rely on us

Preclinical Contract Research Organization

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.

Contract Research Organization

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

What else can we do for you?

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?

“Наша миссия - оказать максимально широкий спектр услуг для украинских и иностранных производителей медизделий.”

Имя Фамилия, должность

News

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(Русский) Украинские производители медоборудования наращивают прибыль

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(Русский) Что такое «орган оценки соответствия»?

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(Русский) Актуальные вопросы по оценке соответствия Техрегламентам медизделий ...

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16.10.2017
(Русский) Медицинские изделия

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Events

16.10.2017
(Русский) Новые правила на украинском рынке изделий медицинского назначения

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16.10.2017
(Русский) Уполномоченный представитель производителя медицинских изделий: ...

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16.10.2017
(Русский) Актуальные вопросы по оценке соответствия Техрегламентам медизделий ...

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16.10.2017
(Русский) Актуальные вопросы по оценке соответствия Техрегламентам медизделий ...

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