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Pharmacovigilance

Pharmacovigilance activities are one of the most frequently outsourced functions of the companies. And it will give not only saving up to 70% of the budget, but ensures maintaining peace and order of the customer-company management as well.

You can choose any below mentioned services and be sure of the quality result and that it will be received exactly on time. Our prices turn out to be below expected (as per opinion of our customers), which can also make you happy.

Pharmacovigilance services are provided in full conformity with the modern GVP and EAEC requirements, and local legislation.

PSUR, DSUR reports (period safety update report on the registered product/investigational product) – average issuing time is 6 weeks. The required initial information prior to project review starts and timeframe will be fixed: the instruction leaflet, and clinical investigation brochure. Then the missing information is requested.

RMP (risk management plan) – issuing takes 8 weeks in average. The instruction leaflet, clinical and preclinical study reports are required for calculation.

Pharmacovigilance master-file can be issued if the required SOPs (standard operational procedures) are available in 4 weeks in average.

Audit of the pharmacovigilance system is the most sought-after service, as far as the relevance of the regular self-inspections and independent inspections is specified by the current requirements.

Writing of SOPs (standard operational procedures) – the average duration of the required SOP package issuing is 8 weeks; the timeframe for this direction is highly customized and depends upon many factors.

Literature Monitoring – we are ready to take over this direction completely. Waiting for the challenge and the list of the products for calculations.

Assignment of the QPPV (qualified person responsible for pharmacovigilance) – this service can be provided. The calculations within the project require complete information on the manufactured products and the products still under registration.

QPPV – coaching and other types of training. Usually it is necessary only when the company’s interest is beyond the professional improvement of its employee, but also spreads to his/her unbiased independent evaluation for the confidence of the company’s management. It is useful for the company employee as well – to be sure that the processes realized and the documents issued to full extent comply with up-to-date requirements.

These are only major activities. Everything is strictly company-specific, sometimes urgent issues are to be resolved, the required advice and recommendations to be obtained, all of it is possible and can be discussed.

Our company has adopted a loyalty system, when the customers already work with us, they are given an individual discount on other company products/services.*

*- it is not a public offer