Pharmaceutical Law
We specialize in pharmaceutical law and clinical trials law.
Our services include:
- advice on the marketing of medicinal products,
- the conduct of clinical trials,
- the manufacture of medicinal products,
- the requirements for marketing and advertising of medicinal products,
- the conditions and rules for the circulation of medicines,
- the requirements for pharmacies and pharmaceutical wholesalers,
- the safety of production and circulation of medicinal products, medical devices and dietary supplements,
- pharmaceutical control,
- labor law in the pharmaceutical industry,
- and the safety and protection of data, including sensitive data, in pharmaceutical operations.
Clinical trials
We have extensive experience in advising entities in the clinical trial industry on clinical trial contracts, legal requirements for clinical trials (local and international) and data protection.
We advise companies and entities participating in clinical trials:
- researchers,
- clinical trial coordinators (NCI),
- centers or networks of centers,
- CRO,
- sponsors.
In particular, we advise on:
- contracts: for conducting a clinical trial (Clinical Trial Agreement), for subcontracting the procedure from the clinical trial protocol (Service Agreement), for appointing the National Coordinator (NCI), for monitoring a clinical trial (CRA), contracts with doctors / researchers (employee and B2B), partnership agreements between centers, confidentiality agreements (CDA, NDA, Secrecy Agreement);
- personal data protection (RODO / GDPR, Personal Data Protection Act) – creation and verification of entrustment agreements, creation of appropriate consents for research participants, verification or creation of an information clause, creation of registers, as an outsourcing for the company, we also provide the services of the Data Protection Officer ( DPO).