Registration of new products

Why do drug registration applications get stuck in offices?

Since September 2016, at SanofyvisionIndia Pharma Relations, we have seen dozens of companies that lost time due to minor errors in papers. Most applications return for correction because someone forgot a signature or formatted a file incorrectly. During this time, we have successfully closed 217 cases. We know exactly what working at the Office for Registration of Medicinal Products (URPL) at Al. Jerozolimskie in Warsaw looks like. There, an official has an average of 43 minutes for the initial evaluation of your application. If they find an error in that time, you lose another 4 months for explanations.

eCTD Dossier Without Technical Glitches

Preparing a dossier in eCTD format is not just about sending an email with attachments. It's a rigid structure that must pass system validation. Since founding the company in Poznań, we have prepared 142 such applications that passed without a single technical error. We focus on making every module — from administrative to clinical — compliant with Polish regulations. According to the act, every document must have its place. No unnecessary paperwork and without fluff, we arrange your data so that the system accepts them on the first try.

• Full development of Module 1 (administrative documentation).
• Substantive verification of texts in Polish (SmPC, Leaflet, Packaging).
• Technical validation of XML files before sending to the CESP portal.

National Procedure: Concrete Deadlines

The national procedure in Poland has its whims. The offices know us and know that we deliver complete documentation. This shortens the wait time by approximately 3.2 weeks because officials do not have to send us letters asking to supplement deficiencies. Honestly, we are not the cheapest on the market, but our statistics speak for themselves — 94.6% of our applications pass without a second round of questions. Clear rules of the game mean that from the beginning you know whether your product has a chance for fast registration or if we still need to work on the documentation.

To stop the bureaucratic machine, we check every word in the Summary of Product Characteristics. Heads-up: if your stability tests end in a month, we will not pretend that we'll make it — we'll tell you straight and propose a realistic schedule. Our office in Poznań works Monday to Friday (9:00 AM – 5:00 PM), and we usually respond to emails about the status of a case in 2h 14min. Specifically and to the point.

Experience that Saves Money

Registration errors are not just stress; they are primarily the cost of delayed market entry. The average cost of one month's delay for a generic drug is often in the range of 23,400 PLN in lost margins. We shorten this process because we know where to find the hooks in pharmaceutical law. Since 2016, we have helped 47 companies avoid penalties for formal errors. If you want peace of mind with the Ministry of Health, let's start by checking what you already have in your binders.