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Preclinical trials:
Development of biologically active substances (BAS) production technology
Technological works on finished products
Clinical trials
Registration of BAS and medicinal preparations
Drugs, biologically active substances, and food supplements patenting
Development and registration of biologically active food supplements
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Professional design of a biologically active food supplement composition according to a client’s requirements
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A biologically active food supplement preclinical trials
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Development of a biologically active food supplement production technology
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Clinical trials
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Pilot samples production
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Development of a medicinal preparation Master File for its subsequent registration
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Registration of a biologically active food supplement
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Production of a biologically active food supplement in compliance with a contract concluded |
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ПОБЕДИТЕЛЬ
ПРОГРАММЫ
ТАСИС |
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RESIDENT OF TECHNOLOGY-INNOVATIVE SPECIAL ECONOMIC ZONE IN TOMSK |
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Special offer |
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Overall solutions for drugs and biologically active food supplements production
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Development and patenting of a generic drug
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Development of a generic drug equivalent to a selected prototype
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Development of drugs possessing prolonged action
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Development of sublingual drugs
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Development of liquid medicinal preparations based on a poorly soluble substance
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Unique professional solutions of unconventional tasks in compliance with marketing specialists requirements
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Development of a medicinal preparation Master File in compliance with European Pharmacopoeia.
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Technological works on biologically active substances
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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 the next stage of pharmacological activity screening. Best extracts with high activity and low toxicity are candidates for subsequent drugs design.
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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.
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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.
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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.
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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.
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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.
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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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