PHARMA, LIFE SCIENCES & HEALTHCARE
Who are our Clients?
As a Polish law firm, we provide specialist expertise required by biotech companies, medtech entities, pharmaceutical companies, pharmacies, producers of medicinal products and pharmaceuticals, bio-it companies, hospitals, laboratories, r&d departments, telemedicine companies and distributors in the Polish market
Sale and distribution of medicinal products and medical devices in Poland:
- Legal advice on respective models of distributing pharmaceuticals;
- Authorisation for pharmaceutical wholesale;
- Support in legal issues connected with direct and parallel import,
- Recommendations on distribution channels;
- Distribution to healthcare entities, taking into account public procurement regulations.
Marketing authorization of medicinal products and medical devices in Poland
- Support in registering medicinal products and medical devices in Poland;
- Legal advice in connection with administrative decisions in marketing authorisation;
- Legal assistance in quality, effectiveness and safety of use;
- Representing pharmaceutical companies in administrative proceedings concerning pharmacovigilance of medicinal products and monitoring their safety;
- Representing clients before regulatory bodies in Poland.
Legal assistance to health care entities operating in the Polish market:
- Legal assistance in public procurement to Polish healthcare entities;
- Regulatory legal advice;
- Representing health care entities in registration proceedings;
- Legal advice in purchasing medicinal products and medical devices under Polish pharmaceutical law.
Legal advice in respect of Clinical Trials in Poland:
- Tripartite clinical trial agreements with Polish companies,
- Good clinical practice in operations in Polish market,
- Securing sponsor’s legal interests in clinical trials in Poland under Polish pharmaceutical law,
- Compliance,
- CRF requirements,
- Data protection issues,
- Formal requirements of clinical trials in Poland
- Sponsor’s and investigator’s duties in Poland.
Telemedicine (e-health) in Poland:
- Legal support in remote monitoring procedures in health care;
- Comprehensive assistance in legal issues connected with telenursing, telepharmacy and telerehabilitation;
- Personal data protection issues;
- Drafting and negotiating contracts in telemedicine.
Marketing of medicinal products and medical devices in Poland:
- Marketing and advertising medicinal products and medical devices under Polish pharmaceutical law;
- Advising on requirements in respect of providing information on medicinal products and medical devices in Poland;
- Unfair competition issues.
Contracts in Polish pharmaceutical sector:
- advising on distribution contracts, sale contracts, in-licensing, out-licensing contracts under Polish pharmaceutical law
- legal support in the relations with Polish pharmaceutical entities.
Biotech:
- Collaborations and partnering agreements;
- Cross border agreements;
- Research and development agreements;
- Litigation;
- Intellectual property;
- Personalised medicine services for entities operating in life science.
