Company Profiles

SERVICES

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

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

ПОБЕДИТЕЛЬ
ПРОГРАММЫ
ТАСИС

RESIDENT OF TECHNOLOGY-INNOVATIVE SPECIAL ECONOMIC ZONE IN TOMSK

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
		Bioequivalence investigations
		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.

Company Profiles

The company carries out the following kinds of work:

Identifying biologically active compounds of both synthetic and natural origin for their further use as pharmaceutical substance.
Screening of biologically active compounds for pharmacological activity (new drug search).
Manufacturing technology for the development of biologically active compounds and active pharmaceutical ingredients (APIs).
Analytics (API, impurities, metabolites evaluation; methods development and validation).
Developing technology for the manufacturing of new drugs as well as generics
Development of standard specifications (Technological regulation, Pharmacopoeia monograph).
Preclinical trials of API and drug (GLP and non-GLP studies according to Russian and OECD regulations) – toxicity, pharmacology, metabolism, pharmacokinetics.
Master File preparation for API and drug registration.
Producing Drug pilot samples for clinical trials and registration.
Dossier for clinical trials and drug registration development.
Drug clinical trials management and supervision in GCP compliance (phases I, II and III).
Generic drugs bioequivalence study (clinical trials).
New API and drug patenting.
Food supplements research and development.
Preclinical and clinical trials of food supplements.

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