Dubininskaya str. 57, bld.1, 115054, Moscow, Russia
info@regapharm.com
+7(499)517-95-23
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Service registration of pharmaceutical products (PP)
Registration of active pharmaceutical ingredients (API)
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Localization of pharmaceutical manufacruting in Russia, Europe, Asia and Latin America
GMP certification in Russia and European Union
Business Development and Product Portfolio Management services
F.A.Q.
Selection of a reference drug for making changes to the dossier of a reproduced medicinal product when the original drug is excluded from the state register
Registration of the drug in the Russian Federation according to the rules of the EAEU, while maintaining the current RU in another EAEU country
Clarification on updating safety information for reproduced medicinesвоспроизведенных лекарственных препаратов
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Decision of the EEC Council dated 05/22/2023 No. 60
Accelerated registration of medicines for medical use
RUSSIAN AND FOREIGN LEGISLATION ON REGULATION OF POST APPROVAL VARIATIONS IN THE DOSSIER FOR THE MEDICINAL PRODUCTS
Preparation of Module 1 of the Registration Dossier According to the EAEU Procedure
Analysis of the Provisions of National and EAEU
Legal aspects of medicines evaluation and registration
Registration of medicines — recommendations for applicants
Registration of medicines — typical errors and problems
Рекомендации
How the EAEU Rules affect the advertising of medicines
New opportunities for registration and patenting of medicines
Problems of drug market regulation: Russia and the EAEU
New format for GMP inspections: a view from global regulators and manufacturers
The Russian regulator is developing a remote GMP inspection process in connection with the pandemic
RISK ANALYSIS OF THE DEFICIENCIES FOUND BY THE GMP INSPECTIONS
Analysis of packaging non-compliances identified during Russian GMP inspection
Regulation of the circulation of medicines on the EAEU market
ORDER number 23N
Analysis of nonconformities associated with storage areas detected during GMP inspection
Main violations identified by russian gmp-inspectorate
Registration of reproduced and hybrid drugs in the EAEU
Administrative Regulations of the Ministry of Health of the Russian Federation
Technological or production documentation within GMP in Russia and in the EAEU
The rules of amendments in registration dossier
Requirements for a drug registration dossier in EAEU
Order № 409н from 12.07.2017
Regulations for registration and expertise of drugs in EAEU
The cost of registration of drugs in Russia
Updated Drug registration procedures
Drug operating procedures
General information - registration PP
Launching and marketing new drugs
Drug registration in Russia
Registration of active pharmaceutical ingredients
Preclinical studies
Clinical study
The Drug Act
Registration of pharmaceutical products
Laws and regulations
On the Rules for the Registration and Expertise of Medicines for Medical Use
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Registration of the drug in the Russian Federation according to the rules of the EAEU, while maintaining the current RU in another EAEU country
Registration of the drug in the Russian Federation according to the rules of the EAEU, while maintaining the current RU in another EAEU country
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Service registration of pharmaceutical products (PP)
Registration of active pharmaceutical ingredients (API)
Clinical trials of pharmaceutical products
Complex solutions for introducing your products on the markets of Russia, Europe and Asia
Localization of pharmaceutical manufacruting in Russia, Europe, Asia and Latin America
GMP certification in Russia and European Union
Business Development and Product Portfolio Management services
Dubininskaya str. 57, bld.1, 115054, Moscow, Russia
Tel. +7(499)517-95-23
info@regapharm.com