SanofyvisionIndia Pharma Relations
First-hand knowledge

News and market advice

We write briefly and to the point. About law changes, new rates, and how not to lose your nerves in the office.

How to avoid the 3 most common mistakes in a MoH application
Advice

How to avoid the 3 most common mistakes in a MoH application

Most drug registration applications return for correction due to minor formal deficiencies. We show what an official looks at first. You will learn how to check the validity of certificates and why the PDF format matters. You will shorten the waiting time for a decision by several weeks.

November 12, 2024 5 min read
New registration fee rates for products in 2025
News

New registration fee rates for products in 2025

Starting in January, the amounts that must be paid into the office's account when submitting documentation are changing. We have compared the old and new prices in one table. Check how much Type II variations have increased and how much you will pay for renewing a permit. Plan your budget for the next quarter in advance.

December 4, 2024 3 min read
We shortened the decision waiting time by 42 days
Successes

We shortened the decision waiting time by 42 days

We describe the process of optimizing document flow in one of the Warsaw pharmaceutical companies. Thanks to changing the archiving method and faster dossier verification, the office did not have to ask for supplements. This is concrete proof that order in papers is real money. Read what tools we implemented at the client's.

October 15, 2024 7 min read
Why does the office reject technical documentation?
Knowledge

Why does the office reject technical documentation?

Inconsistency of chemical data with the description in the dossier is the most common reason for refusal. We analyze 12 cases from the last six months where we had to save the situation. Often the problem lies in specialized translations that are imprecise. We suggest how to verify the work of medical translators.

September 28, 2024 6 min read
Changes in the reimbursement act – what do you need to know?
Law

Changes in the reimbursement act – what do you need to know?

The amendment to the regulations introduces new requirements for reimbursement applications. We focus on points concerning generic and innovative drugs. We explain what 'official margin' means in practice for your business. Prepare for talks with NFZ with a new set of arguments.

August 11, 2024 8 min read
Registration of a generic drug in 14 months
Case Study

Registration of a generic drug in 14 months

Normally this process takes about 19 months, but we managed to close it faster. In this post, we show the schedule week by week. You will learn when it is best to submit an application to avoid vacation periods in offices. Smart planning is the key to gaining an advantage over the competition.

July 5, 2024 4 min read

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