Your trusted partner in medical device regulations on EAEU market
We provide the best knowledge and experience for your products
About us
A group of bright individuals who contribute for your best!

More than 10 years of regulatory background both for Russian and CIS markets make us the best choise you can make to assess the best pathway of your MDs circulation with budget estimation and possible timelines as well.

Having experience registering a variety of different devices from class I to class III, from IVD to implants or MRIs we can be your regulatory advisors on any step of MDs been entering EAEU market.

Having both national procedures in every (almost) EAEU state member and EAEU supranational procedure makes defining the best registration strategy is a hard thing.
Recent changes in regulations added the food for thought but did not made the regultory environment more clear.
Whether your products falls under the Decree 552 (so called "fast-track registration for Russia) or you can have a possibility to go for EAEU directly to allow multimarket access?
Or may be it is worth to follow the current process of national registration in Russia, Belarus, Kazakhstan?

So many options can lead to a confusion. And there are also so many differnt opinions on how it is better to act.
Why we?
What kind of services we can provide you?
  • We can assess the medical devices you wish to register and provide different strategies with pros and cons.

  • Already started the process of registration but not sure that the strategy works? We can review and advise if needed.

  • Ready for submission but need 2nd opinion on the dossier? We can audit the files and provide the observation results that can then minimize or avoid findings during review by respective Health Authority.
  • Did you bought existing business or want to localize yours devices in EAEU? We can advise on how it would be better to start with.

  • Not ready to appoint local regulatory or quality representative? We can handle it!

  • Limited with regulatory resources? We can work for you on the outsource maner.
  • Stuck with procedures from your QMS you want to adobt according to local regulations? We can structure it!

  • Wish to have the clear picture on the adverse event reporting? We can draft it!

These are just the common activites we assist you with.
Still not sure how we can support you?
Let's plan the intro call!
We can present us and get known* on your plans.
*We can sign the NDA in advance if needed
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