Registration of a generic drug in 14 months

Why 19 months is a market norm, not a must

Most drug manufacturers submit applications when they are ready, without looking at the work calendar of offices in Warsaw. This is an error that costs an average of 152 days of delay. Statistics from 2021-2023 show clearly: applications submitted in July or December hit vacation periods, which extends the first stage of verification by at least 43 days. At SanofyvisionIndia Pharma Relations, we analyze department workloads and aim for windows when officials have fewer papers on their desks. Thanks to this, our documents do not wait in line but go straight to checking.

Another reason for standstills is the lack of consistency in technical documentation. A standard application returns for correction an average of 3 times. Every such round of questions is an additional 34 days of delay for correspondence alone. We apply the rule: without unnecessary paperwork. We prepare documentation so that it is compliant with the act the first time. In our latest project for a client from Poznań, concerning a cardiology drug, we went through the entire process without a single call to supplement formal deficiencies. This allowed us to save 104 business days compared to the market average.

Logistics must also be remembered. Sending samples for testing at the wrong time can block the process for further weeks. At SanofyvisionIndia Pharma Relations, we have our own status tracking system that checks what stage the case is at every 48 hours. If we see that a letter has been stuck in the chancellery for longer than 4 days, we react immediately. The offices know us and know that we monitor deadlines. This is not a matter of acquaintance, but of reliability and a concrete approach to every page of documentation that leaves our office at 24 Mickiewicza.

Shortening the process by 5 months means that the drug appears in pharmacies 152 days earlier, which generates real profits.

Schedule week by week

The first 4 weeks with us are always an audit of source documentation. We do not start writing the application until we are sure that Module 3 is complete. In July 2024, we detected an error in the manufacturing process description for one of our clients, which took us 19 hours of expert work but saved the project from rejection. Better to spend 11 days on corrections at the start than to lose 6 months on an appeal process. Clear rules of the game require us to be honest with the client from the first meeting, even if the analysis shows deficiencies.

From the 5th to the 12th week, we deal with the preparation of Modules 1 and 2. Our team, consisting of 14 people, works in a double system – one manager prepares the content, and another verifies it for compliance with Polish legal requirements. The average time for preparing a full document package at SanofyvisionIndia Pharma Relations is currently 47 business days. This is 26 days faster than the average for consulting firms in this part of Europe. The key is specialization – each of us handles a specific therapeutic group of drugs.

Between the 13th and 60th week, the actual procedure at the office lasts. During this time, our role is not limited to waiting. We monitor every move and respond to substantive queries within a maximum of 2 hours and 14 minutes of receiving them. Such response speed shows officials that we care about time and that we have full control over clinical data. In 2023, we handled 89 supplementary inquiries this way, of which 94.6% were accepted by the office without further auxiliary questions.

Without unnecessary paperwork – how to avoid errors in module 3

The quality module is the place where stumbles most often occur. From our statistics, 87% of errors concern the active substance specification or analytical method validation. At SanofyvisionIndia Pharma Relations, we do not blindly copy data from the substance manufacturer. We check them with the current European Pharmacopoeia guidelines. In March 2024, we protected a client from a loss of 23,450 PLN by detecting an inconsistency in the certificate of analysis that would have made drug registration in the Polish market impossible.

We work in accordance with the act, but we know where the law gives room for efficient action. We focus on specifics. Instead of writing 50-page justifications, we create concise reports that an official can read in 15 minutes and immediately make a decision. This shortens the substantive analysis time by nearly 18%. Our experience shows that clear rules of the game and transparency in communication with regulatory authorities is the shortest path to obtaining a marketing authorization.

Heads-up: Always check the validity dates of stability tests 3 months before the planned application submission date. This is a trifle that in 2022 stopped 12 of our competitors' projects because the tests expired during the formal evaluation. We at SanofyvisionIndia Pharma Relations have automatic alerts for this in our CRM system. Every client has insight into their project and sees live how many days are left to the next milestone. This builds trust that no advertising or marketing slogan can replace.

The offices know us and know that our documentation is complete from day one, which eliminates unnecessary correspondence.

Concrete financial effects of faster registration

In pharmacy, time is literally money. Introducing a generic drug to the market 5 months earlier allows for a better position in the list of reimbursed drugs. For one of our partners, with whom we have been cooperating since Q1 2023, faster registration meant an additional 4.7 million PLN in revenue in the first year of sales. Such numbers work on the imagination but are the result of boring, painstaking work on every paragraph of documentation. At SanofyvisionIndia Pharma Relations, we don't look for shortcuts; we look for process optimization.

Our effectiveness is measured by the number of decisions issued. Since the company was founded in 2016, we have closed 217 cases with a positive result. The average rating of our services is 4.92 out of 5, given by 118 real regulatory department managers. We are not the cheapest on the market, and we say so openly. However, our rate reflects the time we save for clients. If you calculate the cost of maintaining a team for an additional half-year wait for a decision, our remuneration usually pays for itself within the first 3 months of drug sales.

In summary, registration in 14 months is possible if you have a plan and stick to concrete deadlines. At SanofyvisionIndia Pharma Relations, every day we prove that fighting bureaucracy consists of understanding it, not in wrestling with regulations. If you have a product waiting to enter the market, don't waste time on amateur attempts. Use the experience of people who have cut their teeth on contact with the Ministry of Health and registration offices across the country.