Changes in Permits (Variations)
Fast Changes in Drug Documentation
Since September 2016, we have been helping pharmaceutical companies carry out changes to marketing authorizations. Every delivery standstill is a real financial loss. That's why at SanofyvisionIndia Pharma Relations we focus on concrete deadlines. In 2024, we handled 89 submissions, and the average entry into the register took 34 days. Without unnecessary paperwork and without waiting months for a response from the office.
Type IA and IB Variations
We mainly handle administrative and technical changes that do not require substantive evaluation but require precision. If you change the product name, the address of the marketing authorization holder, or the manufacturing site of the active substance, you must report it according to the act. We prepare full documentation in 4 business days. The offices know us, so we know what errors to avoid so that the application is not rejected at the start.
Why Does Time Matter?
A blocked batch of goods in the warehouse is a problem that affects an average of 12% of our new clients before starting cooperation. Changes in information prints, i.e., in leaflets and on packaging, must be introduced smoothly. Our team in Poznań makes sure that your drugs always have valid permits. At SanofyvisionIndia Pharma Relations we apply clear rules of the game: you provide us with technical data, and we take on the contact with MoH and URPL.
- Preparation of Type IA variation application in 48 hours.
- Monitoring the status of the case every 3 business days.
- Verification of leaflet translation accuracy for legal requirements.
- Coordination of changes in multiple countries simultaneously if you have an international portfolio.
Practical Experience in Numbers
Since founding the company, we have closed 217 cases related to drug variations. We don't promise miracles; we promise procedures that work. In October 2024, we helped BioLek S.A. introduce a change of manufacturing site in a record 22 days, saving their sales plan for the fourth quarter. Honestly, we are not the cheapest on the market, but our formal errors amount to 0.8%, which is an almost unheard-of result in this industry.
Let's Start with Concrete Facts
If you have a list of changes to implement on your desk, don't wait for another audit. We will check your documents and tell you exactly how long the process will take in your case. We act quickly because we understand that in pharmacy time is not just money, but above all, drug availability for the patient. P.S. The first verification of your application's accuracy will take us less than 2 hours.