Consult formal and regulatory affairs environment in Poland

Regulatory Affairs & Compliance for Medicinal Products and Food Supplements in the EU

Our regulatory affairs specialists and quality assurance experts provide end-to-end consulting services for companies planning to launch pharmaceutical products, food supplements, and FSMP in Poland and the EU.

Pharmaceutical Products

We support registration and compliance of:

Our expertise covers EMA and national procedures (DCP, MRP, national, centralized), pharmacovigilance systems (QPPV), and GMP compliance. We prepare:

We ensure compliance with EU pharmaceutical law, including:

Food Products & Nutrition

We provide regulatory strategy and registration support for:

Our services include:

We ensure compliance with EU food law, including:

Medical Devices & Borderline Products

For companies introducing medical devices or borderline products (drug-device combinations, cosmetics with health claims), we:

Why Choose Us?

We reduce legal risks, ensure regulatory compliance, and accelerate time to market for your medicinal products, food supplements, FSMP, veterinary medicines, and cosmetics in Poland and the EU.

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