Life Sciences
What distinguishes our team in the market is the regulatory approach which guarantees an excellent understanding of the expectations in the public health sector set by the regulatory authorities. We support our clients in avoiding disputes with administrative authorities. We have many years of experience not only in legal advice in the area of health, but also in quality assurance, conducting audits, and obtaining quality certificates for medicinal products.
What we do
- Regulatory advice related to the R&D, clinical trials, manufacturing, distribution and advertising of medicinal products.
- Conducting quality audits at API and medicinal products manufacturing sites, contract manufacturing sites, pharmaceutical wholesale sites, in the scope of a full GMP or GDP.
- Regulatory and legal support in administrative proceedings in the field of: quality defects in medicinal products, obtaining a MIA (marketing a and importation authorisation), WDA (wholesale distribution authorisation), pharmacy license, post-inspection GDM or GMP certification or withdrawal of any authorisation issued by Pharmaceutical Inspection.
- Legal and regulatory advice for manufacturers and distributors of medical devices and dietary supplements and food products, including registration, advertising and administrative proceedings.
- Strategic advice on distribution models of medicinal products within Poland, European Union and worldwide, parallel import and export of medicinal products, reimbursement of medicinal products and medical devices.
Let’s Work Together
Contact Info
Address
BLSK KOZŁOWSKI I WSPÓLNICY SP. K.
Leona Kruczkowskiego 6A/41
00-412 Warszawa, Poland
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