We introduce your drugs to the market without the struggle against bureaucracy
We shorten the decision waiting time by 42 days. We prepare documentation that the Ministry of Health approves without unnecessary questions. Clear rules and zero hidden costs.
217
Registered products
34
Days for variation approval
97.3%
Application effectiveness
8.4
Years of experience in Poznań
Prices without hidden asterisks
We provide net amounts. We do not charge for every letter sent. Concrete rates for concrete work.
Dossier Verification
We check your documents before sending them to the office to avoid rejection.
- Check of 99.3% of technical documentation
- List of 12-15 points for correction
- Report in 48 hours
- Analysis of compliance with the Polish Act
Full Handling
We take on all communication with the office from application to final decision.
- Application submission on your behalf
- Contact with MoH officials every 7 days
- Preparation of responses to comments
- Guarantee of meeting statutory deadlines
PV Supervision
Constant care over the safety of your drugs after marketing authorization.
- Monitoring of adverse reactions
- PSUR reports on time
- 24h availability for urgent matters
- Support in Polish and English
How we built SanofyvisionIndia
We have been operating in Poznań for years, step by step clearing paths in the Ministry of Health.
Launch in Poznań
Barbara Zając opens the office at Mickiewicza St. We start by serving two local wholesalers.
Hundredth drug on the list
We celebrate the hundredth positive decision for marketing authorization. The team grows to 14 people.
Record fee refund
We recover 1.2 million PLN for the EuroMedic client due to incorrectly calculated official fees.
Process digitization
We implement a system that shortens the dossier verification time by 19 days. The offices know us and trust our files.
News and market advice
We write briefly and to the point. About law changes, new rates, and how not to lose your nerves in the office.
How to avoid the 3 most common mistakes in a MoH application
Most drug registration applications return for correction due to minor formal deficiencies. We show what an official looks at first. You will learn how to check the validity of certificates and why the PDF format matters. You will shorten the waiting time for a decision by several weeks.
New registration fee rates for products in 2025
Starting in January, the amounts that must be paid into the office's account when submitting documentation are changing. We have compared the old and new prices in one table. Check how much Type II variations have increased and how much you will pay for renewing a permit. Plan your budget for the next quarter in advance.
We shortened the decision waiting time by 42 days
We describe the process of optimizing document flow in one of the Warsaw pharmaceutical companies. Thanks to changing the archiving method and faster dossier verification, the office did not have to ask for supplements. This is concrete proof that order in papers is real money. Read what tools we implemented at the client's.
Why does the office reject technical documentation?
Inconsistency of chemical data with the description in the dossier is the most common reason for refusal. We analyze 12 cases from the last six months where we had to save the situation. Often the problem lies in specialized translations that are imprecise. We suggest how to verify the work of medical translators.
Changes in the reimbursement act – what do you need to know?
The amendment to the regulations introduces new requirements for reimbursement applications. We focus on points concerning generic and innovative drugs. We explain what 'official margin' means in practice for your business. Prepare for talks with NFZ with a new set of arguments.
Registration of a generic drug in 14 months
Normally this process takes about 19 months, but we managed to close it faster. In this post, we show the schedule week by week. You will learn when it is best to submit an application to avoid vacation periods in offices. Smart planning is the key to gaining an advantage over the competition.
Calculate the approximate cost of application handling
Check how much it may cost to prepare documentation for your product based on working time.
This is an approximate valuation. We will provide the exact cost after reviewing the drug dossier.
Ready to enter pharmacies?
Don't wait for the office to write to you themselves. Take the initiative and close the process this quarter.
Book a consultation date97.3%
Effectiveness in 2024
Fast track
A preliminary analysis of your case will take us no more than 48 hours.