Consult formal and regulatory affairs environment in Poland

Our experts are experienced in regulatory affairs and quality assurance. We can analyse the regulatory environment of the product you intend to launch in Poland for you – we will register it and check compliance of the composition and specifications with Polish regulations.

We will analyse product descriptions and labelling. We will minimise legal risks associated with possible conflicts with the law on advertising of medicinal products or with attributing medicinal properties to products that do not meet the definition of a medicinal product in Poland. You will learn about formal obligations and we will draw your attention to the local administrative bodies – we can represent you at every stage of the registration of pharmaceutical and nutritional products for both humans and animals.

We are familiar with GMP, ISO 9001, ISO 13485, HACCP systems and standards. We are well versed in Polish and EU regulations and will establish the registration requirements for products such as dietary supplements, food for special medical purposes, medical devices and medicinal products (OTC, Rx), products introduced under the General Product Safety Regulations and the Reach Regulation, animal feed mixtures.

We participate in numerous inspections carried out by Polish authorities – we know what to look out for.