Questions and concrete answers
We know official procedures inside out. We answer briefly and to the point, without unnecessary paperwork and fluff.
How long does drug registration or documentation change really take?
According to the act, official deadlines are rigid, but errors in documentation can extend them by many months. In 2024, our average time for approval of a variation was exactly 34 days. We make sure the dossier is complete and error-free before submission to the office.
Do you help in reimbursement negotiations with the Ministry of Health?
Yes, we represent pharmaceutical companies in product funding talks. Last year, we helped obtain reimbursement for 7 key preparations. We prepare hard economic analyses and applications that go straight to the relevant departments of the Ministry of Health.
What are the service costs and can the price increase?
We apply clear rules of the game. An audit of 99.3% of your technical documentation costs 4,320 PLN net. Full registration handling of one drug is priced at 12,740 PLN net. We do not charge for every letter sent or short phone consultation during the project.
What happens when the office sends comments on a submitted application?
We act instantly. We usually respond to official comments within 48 hours. We have a case where we saved a rejected technical dossier in 19 days, correcting chemical data and submitting a re-application that passed without any questions.
What does your Pharmacovigilance supervision look like?
Currently, 23 marketing authorization holders have entrusted us with drug safety supervision. We maintain an adverse reaction reporting system and send PSUR reports always on time. We guarantee constant contact 24 hours a day in case of urgent medical signals.
Where is your office located and do I have to come in person?
SanofyvisionIndia Pharma Relations office is located at 24 Mickiewicza St in Poznań. We have been operating here since September 2016. Most cases are handled remotely, but if you prefer personal contact, you are welcome Monday to Thursday from 8:30 AM to 4:30 PM.
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Effectiveness in 2024
Fast track
A preliminary analysis of your case will take us no more than 48 hours.