Specialized legal services

We focus on providing consultancy services to companies in the pharmaceutical, food (with particular emphasis on dietary supplements), medical devices, and cosmetics sectors.

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About Food & Pharm Legal

Compliance in the pharmaceutical industry

Running a business based on the sale of medicinal products, medical devices, or food products can be very complex. Every new law, regulation, or guidalines issued by authorities poses new challenges for those working in the healthcare and health-promoting industries. As lawyers, we are always able to provide support with up-to-date knowledge of pharmaceutical law, medical devices, or food products, and to clarify common industry uncertainties, such as the labeling of specific product categories or the preparation of distribution agreements. The scope of compliance-related issues is much broader, and we successfully advise clients on all of these issues.

Pharmaceutical industry consulting – what’s worth knowing?

The most important scope of knowledge required when working in the pharmaceutical industry is familiarity with the legal provisions applicable to businesses, as well as the practices related to the application and interpretation of these provisions. Unawareness of these provisions not only does not exempt one from potential negative consequences but may also expose one to relatively high fines or other sanctions.

Food & Pharma Legal

specializes in providing a wide range of legal services to companies operating in the life sciences industry, including pharmaceuticals, medical devices, food products, and cosmetics.

Due to our extensive experience,

we provide our clients with full support in the product launch process, product registration, client representation before regulatory authorities, and more.

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Compliance – compliance of activities with standards and recommendations

Understanding the legal complexities of the pharmaceutical industry is crucial to ensuring companies’ compliance with applicable laws. In a rapidly evolving regulatory environment, companies must stay up to date with the latest legal requirements and their interpretation to avoid potential sanctions and maintain their market position. Food & Pharma Legal offers comprehensive compliance advice (ensuring compliance with legal norms and guidelines from authorities, assisting clients in interpreting and implementing regulations regarding the sale of medicinal products, dietary supplements, cosmetics, and medical devices. Due to extensive experience and expert knowledge, we provide support at every stage of business operations in the pharmaceutical, food, and cosmetics sectors.

Our services include:

advice on wholesale and retail trade in medicinal products – we help companies meet legal requirements related to the distribution and sale of medicines;
preparing and reviewing distribution agreements and other contracts – we prepare contracts tailored to the specific nature of our clients’ business, ensuring their compliance with applicable regulations;
support in product classification, including so-called borderline products – we help determine whether a given product should be treated as a medical device, dietary supplement, cosmetic or medicinal product;
advice on the marketing of CBD and other hemp products – we analyze legal and regulatory aspects related to products containing CBD and other hemp-derived substances;
assistance in obtaining permits and in product registration – we support clients in the process of registering drugs, dietary supplements and medical devices, both on the domestic and European markets;
applying for official pricing and product reimbursement – we advise on pricing strategies and reimbursement procedures, helping clients obtain favorable conditions;
representing clients before supervisory authorities – we provide support in contacts with institutions such as the Chief Pharmaceutical Inspectorate, the Chief Sanitary Inspectorate, the Office for Registration of Medicinal Products and the European Commission;
compliance training and audits – we organize workshops and training in the field of legal regulations and conduct regulatory compliance audits;
handling legal disputes and administrative proceedings – we represent clients in court and administrative matters, including pharmaceutical law and competition protection.

Offer

What do we offer?

We focus on advising companies in the pharmaceutical, nutritional (with particular emphasis on dietary supplements), medical devices, and cosmetics industries.

Pharmaceutical law

Wholesale and retail trade in medicinal products, preparation of distribution agreements, changes to the distribution system and advice on applications.

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Medical devices

Qualification of products as medical devices and product classes, product labelling and content of instructions for use, placing medical devices on the market.

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Food products

Classification of products, assessment of product composition, including permissible limits, introduction of dietary supplements to the market, preparation and submission of notifications to the Chief Sanitary Inspector.

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Hemp products

Introducing hemp products to the market, support in the procedure of applying for a permit to cultivate hemp and in meeting GACP and GMP requirements and obtaining relevant certificates in this regard.

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