Medicinal products and medical devices
Service description
As part of the legal services we provide, we offer:
- Advice on medicinal products and medical devices,
- Support for conducting clinical and observational trials,
- Advice on conducting genetic tests,
- Advice on data handling (medical data, sensitive personal data),
- Legal support in the field of product registration, advice on choosing the right registration procedure,
- Legal advice on medical software,
- Legal advice on the supplementary protection certificate,
- Support in the qualification of products, in particular the so-called borderline products,
- Handling of notification procedures,
- Drafting and reviewing draft research, research and development, technology transfer, manufacturing and distribution contracts,
- Representation before the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and before the Main Pharmaceutical Inspectorate,
- Support in the field of import, parallel and target import,
- Examination of the registration capability of a trademark with simultaneous examination of compliance with the name of medicinal products authorized for marketing (by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), as well as products covered by the notification of the first placing on the market (by the Chief Sanitary Inspectorate),
- Support regarding GMP and GDP rules,
- Legal support regarding product liability,
- Legal advice in connection with participation in a public procurement procedure,
- Legal support regarding the advertising of medicinal products and medical devices – traditional advertising, native advertising, cooperation with bloggers and influencers,
- Legal support in image crises. Designing models for counteracting image crises,
- Training and workshops,
- Audits,
- Preparation of personalized practical guides for the conducted activity
Contact persons
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