Orlikov alley 5, building 2, Moscow, Russia

+7(499)110-25-29

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Audit Company

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Registering product

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Expertise product

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Consultation of auditors

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Preclinical studies

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Training of auditors

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Studies

Preclinical studies The main objective of a preclinical study is to obtain and evaluate the evidence of the efficacy and safety of a medicinal product by applying the scientific method (Federal Law 61, dated April 12, 2010, article 11).


Arranging and conducting preclinical studies of generics include the following services:

For original medicinal products and biosimilar medicinal products, the following parameters should be assessed in addition to the general toxicity:

Bioequivalence studies
We offer our services in designing, arranging, and conducting bioequivalence studies. These services include:

Studies in special populations
Clinical studies in special populations are those phase II and phase III ordinary clinical studies in which per protocol subjects belong to a vulnerable group like children, mental health patients, patients who cannot read or sign the informed consent, and other such categories requiring an additional oversight to ensure the rights of the patients during the study.

Phase I--III clinical studies
A clinical study of a medicinal product breaks into four main phases:

Postregistration studies (phase IV)
Phase IV evaluates the drug after its approval (registration) for the following purposes:

Company informations

Company
LLC EurasiaPharmConsulting

Orlikov alley 5, building 2
Moscow, Russia


Location:
Luzhnetskaya embankment, 6, building 1
Moscow, Russia

Contact details

E-mail address:
info@gmp-audit.ru

+7(499)110-25-29

Available 8:00 - 18:00