Our Services
We Provide Assistance in Registration of the Following Medicines in Аccordance with the Requirements of the Euraisian Economic Union (EAEU):
Original Medicines
A medicine with a new active ingredient, which was the first to be registered and placed on the world pharmaceutical market on the basis of a dossier containing the results of complete preclinical (non-clinical) and clinical studies confirming its quality, safety and efficacy.
A medicine with a new active ingredient, which was the first to be registered and placed on the world pharmaceutical market on the basis of a dossier containing the results of complete preclinical (non-clinical) and clinical studies confirming its quality, safety and efficacy.
Orphan Medicines
A medicine intended solely for the diagnosis or pathogenetic treatment (treatment aimed at the mechanism of disease development) of rare (orphan) diseases. Rare (orphan) diseases are diseases that have a prevalence of no more than 10 cases per 100,000 population.
A medicine intended solely for the diagnosis or pathogenetic treatment (treatment aimed at the mechanism of disease development) of rare (orphan) diseases. Rare (orphan) diseases are diseases that have a prevalence of no more than 10 cases per 100,000 population.
Generic Medicines
A medicine that has the same quantitative and qualitative composition of active ingredients and the same dosage form as the original drug, and whose bioequivalence to the original drug is confirmed by appropriate bioavailability studies.
A medicine that has the same quantitative and qualitative composition of active ingredients and the same dosage form as the original drug, and whose bioequivalence to the original drug is confirmed by appropriate bioavailability studies.
Radiopharmaceutical medicines
A medicinal product containing one or more radionuclides (radioactive isotopes) as an active substance or as part of an active substance in a ready-to-use state.
A medicinal product containing one or more radionuclides (radioactive isotopes) as an active substance or as part of an active substance in a ready-to-use state.
Well-studied medical use medicines
A medicine which active substance has been well studied in the course of medical use, while its efficacy and safety are recognized, confirmed by bibliographic references to published data on post-registration and (or) epidemiological studies, and at least 10 years have passed since the date of the first systematic and documented use of the active substance(s) of this medicinal product in at least 3 Member States.
A medicine which active substance has been well studied in the course of medical use, while its efficacy and safety are recognized, confirmed by bibliographic references to published data on post-registration and (or) epidemiological studies, and at least 10 years have passed since the date of the first systematic and documented use of the active substance(s) of this medicinal product in at least 3 Member States.
Biological medicines
A medicine, which active substance is produced or isolated from a biological source and for the description of properties and quality control of which a combination of biological and physico-chemical methods of analysis is necessary with the assessment of the production process and methods of its control.
A medicine, which active substance is produced or isolated from a biological source and for the description of properties and quality control of which a combination of biological and physico-chemical methods of analysis is necessary with the assessment of the production process and methods of its control.
Hybrid medicines
A medicine that does not fall under the definition of a generic medicine if it is impossible to confirm its bioequivalence using bioavailability studies, and also if the active substance (substances), indications for use, dosage, dosage form or route of administration compared to the original drug.
A medicine that does not fall under the definition of a generic medicine if it is impossible to confirm its bioequivalence using bioavailability studies, and also if the active substance (substances), indications for use, dosage, dosage form or route of administration compared to the original drug.
Homeopathic medicines
A medicine produced according to homeopathic technology using homeopathic raw materials in accordance with the requirements of the Union Pharmacopoeia or, in their absence, in accordance with the requirements of homeopathic pharmacopoeias.
A medicine produced according to homeopathic technology using homeopathic raw materials in accordance with the requirements of the Union Pharmacopoeia or, in their absence, in accordance with the requirements of homeopathic pharmacopoeias.
Immunological medicines
A medicine intended for the formation of active or passive immunity, or the diagnosis of the presence of immunity, or the diagnosis (production) of a specific acquired change in the immunological response to allergenic substances.
A medicine intended for the formation of active or passive immunity, or the diagnosis of the presence of immunity, or the diagnosis (production) of a specific acquired change in the immunological response to allergenic substances.
We Provide Other Services Related to the Registration of Medicines in Аccordance with the Requirements of the Euraisian Economic Union (EAEU):
Written and oral counseling
Comprehensive consultation on all issues related to the procedure and terms of registration of medicines, medical devices and biologically active food supplements in the Russian Federation and in the EAEU member countries.
Comprehensive consultation on all issues related to the procedure and terms of registration of medicines, medical devices and biologically active food supplements in the Russian Federation and in the EAEU member countries.
Registration strategy development
Creating registration strategies for medicines at any stage of development and circulation.
Creating registration strategies for medicines at any stage of development and circulation.
Inquiry handling
Preparation of inquiries and responses to inquiries to the regulatory authorities of the Russian Federation and the EAEU.
Preparation of inquiries and responses to inquiries to the regulatory authorities of the Russian Federation and the EAEU.
Scientific reviews
Writing scientific reviews on preclinical and clinical studies.
Writing scientific reviews on preclinical and clinical studies.
Development of SmPC and PL for any medicine
Preparation of instructions for medical use (SmPC, PL).
Preparation of instructions for medical use (SmPC, PL).
Preparation of amendments to registration documents
Preparation of justifications and amendments to registration documents.
Preparation of justifications and amendments to registration documents.
Seperate dossier modules in the CTD format
Preparation of separate modules of the dossier in the CTD format according to the rules of the EAEU.
Preparation of separate modules of the dossier in the CTD format according to the rules of the EAEU.
Preparation of amendments to registration documents
Preparation of justifications and amendments to registration documents.
Preparation of justifications and amendments to registration documents.
We Provide Other Services:
Market access strategy development
Advice on all issues related to market access of the Russian Federation and the EAEU member countries: market research, development of a sales and marketing strategy.
Advice on all issues related to market access of the Russian Federation and the EAEU member countries: market research, development of a sales and marketing strategy.
Professional translation
Professional translation of documentation for foreign manufacturers.
Professional translation of documentation for foreign manufacturers.
Professional packaging design
Professional design and redesign of the packaging of medicines, dietary supplements and medical devices. Creating an image for packaging, adapting the existing layout to the standards and requirements of the Russian Federation and the EEU countries.
Professional design and redesign of the packaging of medicines, dietary supplements and medical devices. Creating an image for packaging, adapting the existing layout to the standards and requirements of the Russian Federation and the EEU countries.