RegMed - Drugs certification, substances certification
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Welcome! Certification in Russia!

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

 

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Drugs certification, substances certification

We’ve been operating in the sphere of registration of medicines and pharmaceutical substances for more than 10 years. During all this time we’ve gained huge experience enabling us to solve various challenges that arise in the course of the registration process. Much has changed during these years. We were 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 drugs:

  • Federal Governmental Organization «Scientific Center on Expertise of Medical Application Products»
  • Ministry of Health and Social Development of the Russian Federation
  • Federal Service on Surveillance in health care and social development of Russian Federation;
  • Institute of Standardization and Control of Pharmaceutical Preparations;
  • Institute of Preclinical and Clinical Trials
  • Federal Governmental Organization « Scientific Institute of toxicology» (Saint-Petersburg);

Some our customers: 

  • Gedeon Richter Plc., Hungary ; projects: registration of generic medicines
  • GALENIKA CRNA GORA D.O.O., Montenegro ; project: registration of immunobiological medicine
  •  Joint-Stock company “FARMAK”, Ukraine; projects: registration of generic medicines
  • Warsaw Herbal Factory, Poland ; project: registration of original medicine (renewal)
  • LDP Laboratorios Torlan, Spain; project: registration of generic medicine
  • G.Pohl-Boskamp GmbH & Ko.KG, Germany; progect: registration of original medicin
  • Tarchomin Pharmaceutical Works “POLFA”, Poland; projects: registration renewal, registration of changes in generic medicines
  • Nobel Ilac Sanayii Ve Ticaret A.S., Turkey; projects: registration of generic medicines
  • Beres Pharmaceuticals Ko.Ltd, Hungary; projects: registration of original medicine (renewal) 
  • Medical Developments Internacional Ltd, Australia; project: registration of new indications for generic medicine
  • Himalaya herbals (India) ; project: registration of original medicine
  • Melsmon Pharmaceutical (Japan) ; project: registration of original medicin
  • Pharmactives (Russia); project: registration of generic medicine, clinical trials (oncology)
  • Pharmselect (Russia); project: registration of changes (holder of Registration Certificate)

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 drug.

Here you can find a service scope.

 



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