Our Partners' View

We can talk about our achievements for a long time but we think it's immodest. Only a partner's opinion can express all the fullness of real relationship during registration of medical products. The Director General of the ELANSKIN company expressed his opinion...

"Dear Colleagues and personally Oksana Yurievna Balueva!

On behalf of the ELANSKIN personnel and on my own behalf, I wish to express my sincere gratitude to the QUALITY ALLIANCE company and personally Oksana Yurievna Balueva for the job they've done!

We could write standard words of gratitude here, use common phrases and words but it wouldn't have expressed our attitude towards the company formed during the hard process of obtainment of the marketing authorisation (MA). It wasn't easy to obtain MA as for some reasons we hadn't taken a proper approach to this process.

This letter is to express gratitude but it's also for the future clients of the QUALITY ALLIANCE company. I hope that it will help them to make the right choice of the company which will lead them to obtainment of MA.

Our company filed an application for obtinment of MA for a medical product of the 3rd risk class which is the maximum risk class. Thus, this class is the hardest to obtain in terms of issuance of primary documentation and carrying out of all necessary tests.

Dear future client of the QUALITY ALLIANCE, you should know that if you decide to cooperate with this company, everything that the specialists and personally Oksana Yurievna say is 110 percent right. There is nothing unimportant in this process. You should collect documentation with maximum thoroughness during the first stage. Everything is important: Even commas and periods. I'm serious about commas and periods when they are contained in translation of certificates or the company name. Make sure you have all necessary documentation and certificates before you decide to obtain MA for your products if you file application for another manufacturer or you are the manufacturer yourself. Everything you're told about the registration process is exactly what is necessary. The QUALITY ALLIANCE has created a unique algorithm of documentation collection which will allow you to optimise your time and money significantly. Correctly collected documentation set is the basic premise for passing the Roszdravnadzor primary documentation review stage. If anything is not clear for you, you are always welcome to call, write or even visit their great office. They are always open for you and will give you the information with pleasure if anything is not clear for you.

And another important advice about foreign language documentation. Perform its translation and legalisation thoroughly (notarial translation and certification). If you are not sure, contact the company and they will recommend you the best experts in this area.

Due to poor translation performed by the agencies in our home city, we've lost a lot of time and suffered additional expenses.

After positive decision of Roszdravnadzor concerning the primary documentation, it gives permission for further registration procedure which is the second stage: Clinical trials. During this stage, like during the primary documentation submission stage, additional documents or samples may be requested by the experts supervising your dossier in Roszdravnadzor. Of course, you can boil over as you'll have to request new documents or samples in accordance with the form. We had such experience. Of course, we can't say we shone with happiness, but Oksana Yurievna calmed us down.

After successful passing of the clinical trials, the decision on issuance or non-issuance of MA is being made.

You already know that we were obtaining MA for a medical product No. RZN 2015/3526 dated May 17, 2018.

Here, I would like to speak about Oksana Yurievna herself. I'd go as far as saying that we've become friends during obtainment of MA. Believe me, she is not just the head of the company who only cares about getting a customer. Oksana Yurievna empathizes all this process, she always walks in the customer's shoes more than the customer itself. I think that such attitude is priceless. Some problems seemed very complicated to be solved due to reasons beyond control of our company and the QUALITY ALLIANCE company. Oksana Yurievna was concerned not less than we were. Because this woman always does her job until the end regardless of its complexity and all obstacles which may appear on her way.

I hope that Oksana wouldn't mind me writing this. When we received information about the positive decision about issuance of the marketing authorisation for our company, she shed a few tears.

Oksana Yurievna is an undoubted professional, the locomotive of the QUALITY ALLIANCE company who has gathered the best professionals in her company. A special thanks goes to the Head of the Expertise Department Oksana Evchenkova who was assigned responsible for our dossier.

In the beginning of this letter of gratitude, I wrote that it will help make the right choice of a company which will lead you to obtainment of the marketing authorisation. I hope this letter has helped you to make your choice.

Sincerely yours, Director General
D.B. Klyuykov
Press about us
By Ksenia Balueva: «I See Many Advantages in the Customs Union establishment»

The Customs Union establishment is perhaps the key economic achievement. It may and must be regarded from two angles. Firstly, it is the impact produced by the Customs Union establishment on the global and economic situation of Russia, and secondly, such event will undoubtedly affect participants in trade and foreign economic relations. We asked Ms. Ksenia Balueva, General Manager, “ALIANS KACHESTVA” (QUALITY ALLIANCE), to express her opinion on the impact of the Customs Union establishment on Russia and Russian businessmen. The Company's comprehensive services imply the knowledge of regulations in goods registration and certification.

Our Achievements
What We Guarantee
  • Quality guarantee and compliance with deadlines
  • Preparation (development) of documents for procedure of the state registration of medical products is held in strict compliance with Decree of the Government of the Russian Federation No. 1416 dated 12/27/2012 "On Approval of the Rules of the State Registration of Medical products", with Order of the Ministry of Health of the Russian Federation No. 1353n dated 12/21/2012 "On Approval of the Procedure of Organisation and Carrying out of Expertise of Quality, Efficiency and Safety of Medical products".
  • Regular provision of information on every stages of the registration procedure for the partners.
  • Guarantee of originality and genuineness of all issued and granted documents.
  • Confidentiality of information not only in the course of cooperation but also after execution of liabilities under contract.
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