Registration of 3 cardiology drugs in 11 months
For a generic industry client, we conducted a full registration process for three new preparations. Thanks to the elimination of dossier errors at the audit stage, officials did not send a single request for supplementation.
Med-Silesia Pharma wanted to enter the market with three new hypertension drugs. The traditional path in Polish offices often lasts years due to documentation errors. We closed the entire process in 11 months, allowing the company to start sales much earlier than planned.
The challenge
The client had previously tried to register these preparations independently, but after 8 months received a list of 27 comments on the dossier from URPL. Every such comment means another 30 days for a response and a standstill in the project. Losses due to the lack of the drug in pharmacies amounted to approximately 14,280 PLN daily. The problem was an inconsistent chemical analysis in Module 3 and errors in translations of the Summary of Product Characteristics (SmPC), which is critical for officials.
Our approach
We started with a full documentation audit in March 2023. Our team (3 people, including Mariusz Wiśniewski) analyzed the dossier point by point for 19 business days. SanofyvisionIndia Pharma Relations has conducted 217 similar cases since September 2016, so we knew exactly where to look for errors. We applied clear rules of the game – instead of sending hundreds of letters, we prepared one perfect eCTD documentation package.
The solution
We fixed errors in bioequivalence studies and prepared answers to 12 potential official questions before they even asked. We took over all contact with the Ministry of Health and URPL. Honestly, we are not the cheapest on the market, but with us, concrete deadlines count. Because the offices know us, the documentation passed through desks without unnecessary standstills. Everything happened in accordance with the act, without looking for shortcuts.
Results
All three cardiology preparations received marketing authorization without a single call to supplement deficiencies. This is a rarity with such difficult molecules.
Timeline
-
March 14, 2023Start of dossier audit and catching 27 critical errors
-
May 19, 2023Submission of corrected applications to URPL through our portal
-
October 04, 2023Positive substantive verification without office comments
-
February 09, 2024Issuance of marketing authorization for 3 drugs
"The dossier situation was a stalemate; we were losing thousands of PLN every day of delay. The team from SanofyvisionIndia Pharma Relations took it upon themselves and simply delivered the result. Without unnecessary paperwork and fluff."