SanofyvisionIndia Pharma Relations
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Marek Wiśniewski

Senior Registration Specialist

Marek Wiśniewski

info@sanofyvisionindia.com

URPL registration proceduresMarketing authorization of drugsType IA and IB post-registration changesPharmacovigilance supervision

Concrete support for documentation

Marek is the person at SanofyvisionIndia Pharma Relations who makes sure that every application sent to the office is complete from the first to the last page. He joined us in September 2016, right after working in medical administration in Poznań for 8 years. He knows every path in the Office for Registration of Medicinal Products (URPL). He doesn't play at writing long emails that lead nowhere. If one attachment is missing from your documentation, Marek will catch it in 14 minutes before the documents hit the official's desk.

In 2024 alone, Marek handled 37 cases ending in a positive decision for marketing authorization. His working method is simple: he reads the regulations as they are written, not as someone thinks they should be. Thanks to this, our clients do not waste time correcting obvious errors. He knows that in this business, concrete deadlines count, not promises without backup. Without unnecessary paperwork and without circling around the topic – that's what consultations with Marek look like.

Experience that shortens the wait time

Over the last few years, Marek has specialized in national procedures and post-registration variations. The average time in which he prepares a full package of documents for an application is 11 business days. This is a result he worked out through hundreds of hours spent on the analysis of legal acts and contact with the Ministry of Health. He doesn't believe in magic; he believes in order in papers. The offices know us precisely because of the reliability that Marek presents.

  • Effective preparation of applications for permit renewal (43 successfully completed in the last year).
  • Handling processes for generic and innovative drugs.
  • Verification of packaging texts and leaflets for compliance with the current act.
  • Direct contact with coordinators at URPL on urgent matters.

Marek starts work every day at 7:30 AM because as he says himself – in the morning, the mind handles tables and ATC codes best. If you need to know what stage your case is at, you will get concrete information from him in less than 45 minutes. He can be direct and doesn't beat around the bush if he sees that a given product does not meet formal requirements. This honest approach saved our clients a total of over 1.2 million PLN on official fees for applications that would have been rejected anyway.

After hours, Marek renovates old mechanical clocks. He says that mechanisms and pharmaceutical law have one thing in common: everything must fit together to the millimeter, otherwise the whole system stops. Heads-up: if you plan on submitting an application in December, get in touch with Marek no later than November 12th, because that's when he closes the schedule for the end of the calendar year.