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Welcome!

We are the Expert Group “RegMed prof.”!

 

For 10 years we’ve been representing the interests of pharmaceutical and dietary supplements producers in the state registration agencies.

 

WE

Are professionals and are ready to solve the most extraordinary tasks
Are experts in our business and take pleasure in doing it
Love our customers and recognize importance of time to them
Render a complete package of registration services

 

Our services:

- Preparation of documents for registration of medicines, medical equipment, biologically active dietary supplements, perfumery and cosmetics products and dietetic food.
- Representation of producers’ interests in state registration agencies of units designed for medical application (accompanying and control till obtainment of the Marketing Authorization.
- Organization of clinical tests
- Organization of sanitary and epidemiological expertise
- Execution and formalization of licenses for import/export of products
- Execution and formalization of licenses for pharmaceutical activity
- Certification in GOST R system
- Certification in the system of sanitary and epidemiological control

 

SEARCH

Certification of medical devices

We’ve been operating in the sphere of registration of medical equipment and units designed for medical application for more than 3 years. During all this time we’ve gained huge experience enabling us to settle various problems that arise in the course of the registration process. Much has changed during these years. We’ve been flexible enough to adjust to all the changes that made the registration process more difficult and at the same time improved it. Due to this fact more and more recognized producers entrust to us this responsible and challenging work.

 

During the registration process we represent and protect the interests of our customers in all the  bodies involved in registration of medical devices:

  • Federal service on Surveillance in healthcare and social development (Roszdravnadzor)
  • Scientific research and test institute of medical device
  • Federal Center of hygiene and epidemiology
  • Federal Governmental Organization «Scientific research institute of transplantology and bioartificial organs»
  • Federal Governmental Organization «Scientific research institute of physical-chemical medicine»
  • Federal Service on Defense of Consumers’ Rights and wellbeing
  • Federal Governmental Health Care Organization «Information methodological Center «Expertise»

Some our customers and projects:

  • «Diaglobal» (Germany); project: registration of mobile laboratory, tests and standards kits
  • «Wonderline» (Spain); project: registration of hygienic pads
  • «Delta Med S.r.l.» (Italy) : project: registration of medicinal clothes
  • "Leventon S.A.U" (Spain); project: registration of disposable pump
  • «Flexicare Medical Ltd» (UK); project: registration of laryngoscopes
  • «Spiggle & Theis Medizintechnik GmbH» (Germany); project: registration of steryl tampons for surgery
  • "NanotechPharma" LLC (Russia); project: registration of medical plaster manufactured using nano-technology
  • "Vismut"LLC (Ukraine); project: registration of applicators
  • "Bicakcilar Tibbi Cihazlar sanayi ve Tacaret A. S."; project: registration of venous pressure measuring device
  • PRESTIZ d.o.o (Slovenia); project: registration of devices for auxiliary  locomotor system therapy
  • CA.MI. di Attolini Mario e C.-S.n.c. (Italy); project: registration of medical aspirators
  • Delta Med S.r.l. (Italy); project: registration of medical gases distribution & supply equipment
  • Provita Medical GmbH (Germany); project: registration of medical lamps.
  • VBM Medizintechnik GmbH (Germany); project: registration of anesthetic respiratory apparatus
  • Primed Halberstadt Medizintechnik GmbH, (Germany); project: registration of catheters for anaesthesiology and reanimatology and resuscitation
  • SIR MEDICAL CO., LTD (Korea); project: registration of disposable sterile syringes

Payment for services is effected in any form convenient for the customer (cash, cashless) and in any currency (rubles, euro, and dollars).

 

The registration process is difficult and labor-consuming; we can take it on us completely or proceed with it from any stage. We are always ready to negotiate and apply different methods of payment.

 

Here you can find a minimum set of documents necessary for registration of a device.

Here you can take a draft copy of Power of Attorney.

 



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