Regulatory consulting in the pharmaceutical industry
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.
What do we offer?
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:
- Advisory services on marketing authorization or notification procedures for medicinal products (human and veterinary), ATMP, medical devices, cosmetics and dietary supplements;
- Consulting services regarding the determination of local requirements in various European and non-European countries (e.g., Canada, Switzerland) concerning various aspects related to the marketing authorization of medicinal products (e.g., requirements for Bollini labels in Italy, searching for an Exploitant in France);
- Consultations on issues related to the import of products from third countries, parallel import, direct import also known as ‘compassionate use’, and hospital exemptions;
- Support in organizing the legalization of documents (GMP certificates, MIA, CPP) at embassies or other state institutions for submission during procedures in third countries.
Why SciencePharma?
For 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.
Collaboration benefits
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.