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   SERVICES
Preclinical trials:
     Development of biologically active substances (BAS) production technology
    Technological works on finished products
       Clinical trials
  • phase I
  • phase II
  • phase III
  •  phase IV
  • Comparative bioequivalence studies
         Registration of BAS and medicinal preparations
  • Development of a medicinal preparation Master File
  • Carrying out a registration procedure
    Drugs, biologically active substances, and food supplements patenting
     
Development and registration of biologically active food supplements
  • Professional design of a biologically active food supplement composition according to a client’s requirements
  • A biologically active food supplement preclinical trials
  • Development of a biologically active food supplement production technology
  • Clinical trials
  • Pilot samples production
  • Development of a medicinal preparation Master File for its subsequent registration
  • Registration of a biologically active food supplement
  • Production of a biologically active food supplement in compliance with a contract concluded
           ИФАР (Инновационные фармакологические разработки)
   TASIS
PROGRAM
WINNER
Special offer
Overall solutions for drugs and biologically active food supplements production
  

Development and patenting of a generic drug
  

Development of a generic drug equivalent to a selected prototype
  

   

Development of drugs possessing prolonged action
  

Development of sublingual drugs
  

Development of liquid medicinal preparations based on a poorly soluble substance
   

Unique professional solutions of unconventional tasks in compliance with marketing specialists requirements
  

Development of a medicinal preparation Master File in compliance with European Pharmacopoeia.
  

Bioequivalence research

In Russia in order to prove a generic drug bioequivalence, a comparison of pharmacokinetics profile in human is used, whereas dissolution test in vitro in other countries is also applied. If development of generic drug is in process we can test the samples bioequivalence in animal evaluation of pharmacokinetics profile of the drugs. To test bioequivalence in human we select an authorized clinic and insure volunteers and management of the study. We also insure all procedures supervision during clinical trials in frame of GCP and Russian regulation. Then obtained data are analyzed, and company’s experts prepare the report of the study.

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