SRC Medical & Pharma

Advising on the establishment and registration of medical facilities, drafting and reviewing internal documentation, regulations and contracts with medical personnel

Representation in cases involving medical errors, hospital infections and other medical events resulting in civil or criminal liability

We provide comprehensive supervision of the compliance of medical facilities and medical professionals with applicable regulations and industry standards, including preparation and review of internal procedures and regulations, also in the area of personal and medical data

Support in proceedings before the Patients’ Rights Commissioner, the National Health Fund, the Minister of Health, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Medical Chambers, sanitary and epidemiological stations, administrative and civil courts

Assistance in preparing bids in tenders for the provision of healthcare services, negotiations and disputes concerning the performance or termination of contracts with the National Health Fund, as well as remuneration under these contracts, including for services provided in excess of limits

Defense of doctors, nurses and other medical personnel in proceedings conducted by medical and nursing chambers and courts

Comprehensive services for medical entities in the area of establishing and terminating employment relationships, labor law disputes and collective disputes

We represent medical entities and members of medical staff in proceedings concerning protection of personal rights

Comprehensive support in the classification, labeling, distribution and advertising of medical devices in accordance with MDR/IVDR regulations and the Medical Devices Act

Advice on obtaining market authorizations for medicinal products and medical devices

Assessment of the compliance of marketing campaigns with legal regulations, support in creation of advertising materials, representation in cases concerning violations of advertising bans

Advising pharmaceutical wholesalers and pharmacy chains, including on permits, storage and distribution requirements for medicinal products and inspections by the Chief Pharmaceutical Inspectorate

Representation before the Chief Pharmaceutical Inspector, the Minister of Health and other institutions in matters concerning inspections, administrative penalties, marketing bans, etc.

Advising on reimbursement applications, negotiations with the Ministry of Health, compliance of pricing policy with the provisions of the reimbursement act

Creation and implementation of regulatory compliance procedures, internal policies for sales, marketing and distribution departments, conducting training for employees

Preparation and negotiation of distribution, licensing, manufacturing, research and development agreements, as well as contracts with medical representatives

We conduct comprehensive audits of compliance with the GDPR and industry regulations, identify risks and implement remedial measures

We develop comprehensive data protection documentation: processing records, privacy policies, information clauses, consents and internal procedures

We provide support in conducting Data Protection Impact Assessments, risk analyses and assessments of compliance of new business processes with the GDPR

We act as an external Data Protection Officer (DPO), providing professional support in supervising the organization’s compliance with data protection regulations

We represent clients in control and dispute proceedings before the President of the Personal Data Protection Office and in administrative court proceedings.

We conduct practical training for HR, operations, marketing, IT and management on GDPR and personal data protection.

We support clients in implementing and using AI-based solutions, ensuring compliance with applicable regulations, in particular the AI Act, GDPR and sector-specific regulations.

We prepare, negotiate and review copyright and license agreements, including those relating to graphic works, multimedia, and software.

We represent clients in court disputes concerning the infringement of economic and moral copyrights

We protect our clients’ interests against acts of unfair competition, including product copying, misleading practices and breaches of trade secrets

We advise on e-commerce, i.e. the sale of goods, sharing of intellectual property and the provision of services via the internet and other means of remote communication.