We shortened the decision waiting time by 42 days
42 days is an abyss in the pharmaceutical industry that determines whether a drug reaches pharmacy shelves before the season or stays in the warehouse. SanofyvisionIndia Pharma Relations proved that shortening this time is possible thanks to a simple change in office habits. Instead of fighting with officials, we organized the papers at the source.
Mess in the dossier cost a fortune
Our client from Warsaw was struggling with a huge backlog in the registration department. In October 2023, 14 applications were lying on the desks, which had been unable to pass through formal verification for months. The Office for Registration of Medicinal Products (URPL) regularly sent requests to supplement deficiencies, which each time froze the process for another 19 business days. The company was losing not only time but real resources, because every hour of downtime meant unfulfilled orders from wholesalers.
An analysis conducted by SanofyvisionIndia Pharma Relations showed that the problem was not the officials' bad will, but chaos in internal archiving. Technical documentation was scattered among three different departments, and the final dossier often contained outdated versions of stability test results. This made a substantive evaluation of the application impossible from the start. We focused on clear rules of the game and a total change in the approach to preparing files.
Every request to supplement documentation is an average of 19 days of delay that can no longer be made up.
The office doesn't have to ask for explanations
We introduced a fast verification system, which we tentatively called 'Sanofy's sieve'. Instead of sending a dossier and hoping for luck, our specialists checked each of the 1,247 sheets for compliance with the current Ministry of Health guidelines. We caught 34 errors in numbering and 12 missing qualified signatures even before the courier shipment. Thanks to this, the first application sent after the changes passed formal verification without a single auxiliary question from the office.
Cooperation with offices requires specifics, not fluff. We focused on making every document readable and easy to find in the electronic system. For this, we used a folder structure that perfectly maps the ministerial requirements. The effect? The time needed to prepare one file was reduced from 5 days to just 3.2 hours, which freed up the processing capacity of the client's entire registration team.
Concrete deadlines and real profits
The most important moment was obtaining a positive decision 42 days faster than the original schedule provided. For the painkiller that was the subject of the application, this meant the possibility of entering 483 pharmacies while still in the peak infection season. SanofyvisionIndia Pharma Relations calculated that this time translated into additional client revenue of 214,000 PLN in the first quarter after registration alone. This shows that our work is not just about filling out forms.
Let's remember that the offices know us and know that we deliver reliably prepared documentation. When an inspector opens a package from SanofyvisionIndia Pharma Relations, they see order and logic. This builds trust that cannot be bought by any advertising campaign. We act in accordance with the act and do not look for shortcuts, because only hard facts defend themselves against official control. Shortening the waiting time is a natural result of a job well done.
A decision 42 days faster means 214,000 PLN of additional revenue in the first quarter of sales.
How to implement these changes at your place?
You don't need a revolution to improve results. It's enough to start with an audit of your own resources. Many pharmaceutical companies in Poland still rely on methods from 2012, which simply fail in the face of today's digitization of offices. Since September 2016, at SanofyvisionIndia Pharma Relations, we have been helping to organize these processes so that they are transparent for every employee and every controller. No unnecessary paperwork and without wasting time correcting obvious mistakes.
If your dossiers return with comments more than twice a year, it's a sign that the system is leaky. On average, we correct 9 out of 10 applications that come to us after the first refusal from the office. Our experience based on 217 completed cases allows us to predict officials' moves far in advance. We invite you to contact us to establish a specific action plan that will help avoid standstills in the coming months.
