+7 (495) 785-71-61
About company
Plantpharma LLC is one of the leaders of the most progressive consulting companies in the field of pharmaceuticals and GMP, carrying out consulting and auditing activities in accordance with Russian and international standards.
Advantages
ProfessionalismQualified specialists of Plantpharma have many years of practical experience of real manufacturing, conducting voluntary pharmaceutical audits, trainings and consulting.
Systems approachAn integrated system approach to audits, namely: a combination of preliminary consulting and training on the results of the audit, with a focus on identified problem areas, allows you to optimize the audit process and increase the efficiency of production processes in the company
ResponsivenessOur experts are ready to be at your manufacturing site within 48 hours after the conclusion of the contract, for consultation, training or voluntary audits.
ReliabilityMore than 200 successful audits and the loyalty of our customers are the best indicators of the effectiveness of our services and the reliability of Plantpharma..
Our services
We provide a full range of services for registration and re-registration of medicines, APIs, dietary supplements, medical equipment and medical devices and consulting of production sites according to the requirements of the Russian GMP standard, voluntary GMP audit of production sites in order to prepare for state inspection and present the interests of our Customers in regulatory bodies.
— Preparation and consultation of manufacturing sites according to the requirements of the Russian GMP standard
—Conducting a voluntary pharmaceutical audit on compliance with GMP standards of pharmaceutical production (Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 No. 916 "On Approving the Rules of Good Manufacturing Practice")
— personnel training on the rules of organization of production and quality control of medicines with an emphasis on the specifics of the requirements of the Russian regulator
—Conducting a voluntary pharmaceutical audit on compliance with GMP standards of pharmaceutical production (Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 No. 916 "On Approving the Rules of Good Manufacturing Practice")
— personnel training on the rules of organization of production and quality control of medicines with an emphasis on the specifics of the requirements of the Russian regulator
— Full range of drug registration services
— Preparation of a registration dossier and other necessary documents, as well as all the support in accordance with regulatory requirements
— Оформление, адаптация, перевод документации, предоставляемой Клиентами, в соответствии с законодательством РФ Preparation, translation of documentation provided by customers, in accordance with the legislation of the Russian Federation
— Submission of a registration dossier to the authorized federal body for state registration of medicines (Ministry of Health of the Russian Federation)
— Registration of dietary supplements and raw materials in Rospotrebnadzor in accordance with the legislation of the Russian Federation
— Preparation of a registration dossier and other necessary documents, as well as all the support in accordance with regulatory requirements
— Оформление, адаптация, перевод документации, предоставляемой Клиентами, в соответствии с законодательством РФ Preparation, translation of documentation provided by customers, in accordance with the legislation of the Russian Federation
— Submission of a registration dossier to the authorized federal body for state registration of medicines (Ministry of Health of the Russian Federation)
— Registration of dietary supplements and raw materials in Rospotrebnadzor in accordance with the legislation of the Russian Federation
Flexible discount system and individual approach
to each Customer
to each Customer
Any questions?
125212, The Russian Federation, Moscow,
Golovinskoye shosse 8, building 2a,
Golovinskoye shosse 8, building 2a,
Phone: +7 (495) 785-71-61
E-mail: info@plantpharma.ru
E-mail: info@plantpharma.ru
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