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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)
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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.
  

Technological works on biologically active substances

     

Extraction of biologically active substances from natural raw materials

The aim of plant, animal or biotechnological raw material extraction is purification of biologically active substances for obtaining concentrated biologically active substance suitable for subsequent drug design.

 

     
 

Separation and identification of biologically active molecules from natural raw material

Natural raw material frequently contains several biologically active molecules. Isolation and identification of such molecules or groups of them is carried out at this stage. Applicable techniques such as FPLC, HPLC for separation and LC-MS/MS or GC-MS for identification are used.

This work is the basis for new natural drug design.

     
 

Technological development for pharmacological substances

Pharmaceutical substance or active pharmaceutical ingredient (API) is a single molecule or mixture that has a main pharmacological effect and is used for drug production. To create an API from a compound with known chemical properties it is necessary to develop methods for evaluating its quality using pharmacopoeia physical, chemical and physicochemical analysis; to determine storage life and storage conditions. All this information is included in the Specification for the pharmaceutical substance.

The development of technology for API isolation ensures the following regulation of all stages of its manufacturing process.

 

     
 

Development of analytical methods for API and impurities

Such work is urgent due to strict management of pharmaceutical substance quality and necessary for quality control during the process of API production, distribution and drug manufacturing.

 

    
 

Validation of analytical methods

The most significant stage of quality control is analytical methods validation, evaluating methods suitability. The validation is carried out according to established rules and standards. Validation report is included in Specification for a pharmaceutical substance and also further used by Quality Assurance department for manufacturing process validation.

 

     
 

Stability control

API’ stability control gives time and conditions for storage as well as technological restrictions for drug production. Report on stability control is a part of API Specification for registration.

     
 

Regulatory documents (regulations, Pharmacopoeia Monograph) elaboration

 

Drug registration is obligatory for both manufacturing and medical application. Pharmacopoeia Monograph and manufacturing regulations are normative documents necessary for pharmaceutical substance registration or authorization procedure and are formulated by strict requirements of Pharmacological Committee regulations. Both documents are included in Drug Master File submitted for official drugs registration or authorization procedure.

 

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