In the tightly regulated pharmaceutical sector, adherence to the appropriate laws and guidelines is essential for conducting activities successfully. Operating in the pharmaceutical industry requires an understanding of a range of EU laws, regulations, and directives, as well as the ability to navigate complex guidance from regulatory agencies, often referred to as ‘soft regulation’. Failing to comply with these regulations may result not only in the denial of marketing approval for a medicinal product but also in exposure to financial liabilities, such as fines or penalties, and could even lead to imprisonment for those found responsible for illegal activities.
At SciencePharma, we provide extensive regulatory consulting. We encourage you to contact us for any problems or questions regarding formal requirements related to registration or re-registration.
We are also willing to tackle unconventional issues such as:
For almost 20 years, we have been implementing various projects and conducting numerous registration processes in Poland, other EU countries as well as non-European countries. This extensive experience allows us to solve unusual problems that may arise outside the EU and to efficiently organize locally required documents.
Thanks to our many years of experience, we efficiently manage projects, solving emerging problems quickly and effectively. Therefore, you can be sure that your project will be actively pursued. With our broad experience, we can prepare the necessary documents, estimate the costs of procedures, and provide the timeframe for each procedure. We are here to support you! Do not wait any longer; let us meet to discuss your project.
Struggling with pharmaceutical law issues?
We are here to support you! Do not wait any longer, let’s meet to discuss your project.