Pharmaceutical law consulting
Operating in the pharmaceutical sector is related to the necessity for companies to know the pharmaceutical law. When writing “pharmaceutical law” we mean both “hard law”, that is all acts, regulations and directives, and the so-called “soft law”, i.e. agency guidelines.
Underestimating the importance of legal documents, which constitute the framework and rules of functioning in the pharmaceutical industry, poses a risk of introducing a product of inadequate quality to the market, which results in a direct threat to the health or even life of the patient, and may result in penalties for the company itself, including fines or even imprisonment.
Knowledge of pharmaceutical law is also useful in planning a project or looking for new paths and solutions to optimize activities in the pharmaceutical market.
What we offer under „Pharmaceutical law consulting”?
Pharmaceutical law consulting in the case of SciencePharma is a broad concept that covers many activities that our experts perform for our clients in the field of Pharmaceutical law. Undoubtedly, if you are struggling with a legal issue and need a consultation – we are here for you. Our service is tailor-made and we always try to support our clients and solve the challenges posed by legal requirements.
The list of topics that we have taken up as part of our service is as follows, although it is not exhaustive:
- Medicinal products (human and veterinary), ATMPs, medical devices, cosmetics, food supplements consultations regarding authorisation/notification
- Support in meeting the local requirements in Poland but also in other EU countries (e.g. Bollini label in Italy, support in finding MAH exploitant in France) and non-EU registration agencies, such as Canada or Switzerland
- Consultations on various types of imports: import from third countries, parallel import, targeted import, compassionate use, hospital exemption and other non-standard methods of introducing a medicinal product to the EU market
- Consultation and assistance in the legalization process of documents (e.g. GMP certificates, MIA or CPPs) in different embassies, such as the embassy of Iraq and others located in Poland
- Assistance in the preparation of various types of legal contracts, including technical contracts required for MAH transfers or quality/distribution contracts
- And much more.
Should you need help with anything that isn’t listed above, please reach out to one of our experts to get more information about our complete portfolio of services.
Thanks to the fact that on board of our team we have experts from the Regulatory Affairs and Law departments, we are able to solve even the most complex pharmaceutical law puzzles. We have experience with all topics listed above (including support in documents legalisation, different agreements preparation, and so on) so you can be sure we have what it takes to assist you with your inquiry.
Thanks to our wide experience we can deal with matters quickly and efficiently. We can guarantee that your project won’t suffer any unnecessary delays and will be actively implemented. Our well-established network of contacts with registration agencies, competent authorities, ministries and embassies help us to demonstrate the scope of the necessary documents, costs and time of individual procedures.
Struggling with pharmaceutical law issues?
We are here to support you! Do not wait any longer, let’s meet to discuss your project.