We are ready to offer you a wide range of services in the sphere of registration, certification and declaration of drug products for medicinal use, which includes facilitation of their marketing and development raising awareness of your brand among other manufacturers on a global scale.
Drug product registration is a regulatory quality evaluation and risk-benefit analysis with purpose of drug's authorization for use within the territory of Russian Federation. Product registration is one of the key stages for new pharmaceutical product launch.
FDF product registration workflow
FDF product registration for medicinal use
Under Act no. 749 from 31 October 2018 product specification file for FDF product must be conditioned to the effective version of State Pharmacopeia
For further details on terms and procedure please contact our specialists: +7 (495) 231-28-61, ext. 28-44 or e-mail SV_GRIGOREV@protek.ru.