Since 2016 ARS has provided a full range of pharmacovigilance services in accordance with the requirements of GVP of the EEU:
Providing a 24/7 hotline
Processing of ICSR at the territory of the Russian Federation (signal management, collection, validation, medical assessment, reporting)
Maintenance of a database of Individual Case Safety Report (ICSR)
Scientific and medical literature and other source screening to detect spontaneous safety reports
Submission of Periodic Safety Update Report (PSUR) to the Regulatory authorities
Monitoring the benefit-risk ratio
Developing of risk management plans
OUR COMPETITIVE ADVANTAGES:
Years of experience in this field
Periodic Safety Update Reports and Development Safety Update Reports
contact us by email,
or fill out the request form.
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