Dr. Anna Banaszewska

Attorney-at-Law - Pharma / Biotech

Profile

Dr Anna Banaszewska’s law firm was established on the basis of her business experience and service to companies operating in the life sciences sector.

Our team consists of solicitors and barristers specialising in pharmaceutical, food and cosmetics law, intellectual property and public procurement law. We act for clients throughout the European Union. We work with the best experts in HTA, development and IT.

We rise to the challenge!
We approach each matter on an individual basis, finding optimal solutions to ensure legal certainty and the achievement of business objectives.

We listen to our clients!
We listen carefully to our clients’ needs. A detailed analysis of business conditions, competition and opportunities enables us to understand the context and conditions in which our client operates.

We find individual solutions!
We understand that when our clients seek solutions to their problems, they expect specific guidelines, conclusions or courses of action.

Our work is based on the search for creative solutions, we respond proactively to change and, in the case of insurmountable obstacles, we break new ground to change the unfavourable situation.

Specialities
1. Clinical trials
We provide legal assistance to those involved in clinical trials, in particular investigators and sponsors. We advise on the preparation of documentation required to obtain authorisation to conduct a clinical trial and on the financing of healthcare services related to the clinical trial. We deal with issues of liability for injuries arising in connection with a clinical trial. We assist our clients with data protection issues related to clinical trials.

2. Pharmaceutical law
We advise on the manufacture, importation, authorisation, marketing and advertising of medicinal products as well as the development process, the qualification of production lines and the validation of manufacturing processes. We draft agreements: licensing, manufacturing, quality (technical). We represent our clients in all countries of the European Union and in third countries (we have experience in Ukraine, Uzbekistan, India, United Arab Emirates, China, South Africa, Tanzania, Kenya, Chile, USA).

We advise on the process of preparing for inspections by GIF or the competent authorities on the territory of the European Union country concerned. We also advise on the best course of action and represent our clients before the national authorities or the European Commission, as well as on permit amendments. We carry out legal assessments of mock-ups and package leaflets.

We provide legal assistance to pharmaceutical wholesalers and pharmacies, including in the areas of authorisation, marketing and advertising of medicinal products.

3. Reimbursement
We represent clients before the Ministry of Health in the process of obtaining reimbursement decisions and setting the official retail price. We advise clients on the choice of the optimal risk-sharing instrument, prepare the necessary documentation and participate in the preparation of the negotiation process.

We cooperate with the leading HTA agencies in Poland and, upon request, we can provide substantive and commercial supervision of the preparation of HTA analyses and the pricing process.

4. Medical devices
We provide legal assistance in the process of production, marketing, distribution and advertising of medical devices. We advise on issues related to clinical evaluation of medical devices. We deal with issues relating to liability for medical incidents. We assist clients in the process of stopping or restricting the marketing or use of medical devices, as well as in the process of withdrawing medical devices from the market.

5. Foodstuffs
We assist in the preparation of documentation required to obtain HACCP certification. We provide legal assistance in the area of food labelling, including claims, nutrition, health marketing and advertising. We advise on the marketing and production of specific types of food, including dietary supplements and foods for special purposes.

6. Cosmetics
We provide legal assistance in the area of manufacturing, including preparation of master documentation of the manufacturing site, labelling of cosmetic products, and marketing and advertising. We prepare the production site for inspection and represent it in proceedings before the Sanitary Inspection Authorities, draft production contracts, including contract manufacturing, technical agreements and licence agreements.
7. Personal data
We prepare, review and adapt for use in the Polish market documentation related to the processing of personal data, such as security policies, policies on the permitted use of IT equipment or systems.

8. Litigation and Arbitration
We represent our clients in court proceedings, including before the Supreme Court and the Supreme Administrative Court. We provide a full range of litigation services, from developing litigation strategy and advising on evidence gathering, through the pre-trial summons stage and ancillary proceedings, to participation in the main proceedings.

9. Trade marks
We conduct trademark searches, prepare trademark applications and represent clients in trademark disputes. When analysing the protection of a trademark, we take into account the intended use of the trademark and check whether the trademark in question can be used as an invented name for a medicinal product, depending on the name in common use (INN) and the marketing authorisation procedure.

10. Legislation
We actively participate in public consultations on draft legislation in areas of interest to us. We monitor legislation for our clients and advise on new legislative solutions. We advise on the progress of the legislative process.

11. Training
We provide training, lectures and workshops in each of our areas of expertise. We participate as speakers in conferences and seminars organised by many prestigious institutions and organisations, including industry associations and private companies. We also conduct closed training courses for all of the client’s employees or for individual teams.

Our Law Firm is a partner of the post-graduate courses in Pharmaceutical Law for Business and Health Care Management at Kozminski University.

12. Labour Law
We provide legal assistance in the field of labour law to clients from the medical and pharmaceutical industry.

As part of our labour law services, we represent employers and employees in labour disputes for clients in the medical and pharmaceutical sectors.