Welcome to ADMA Ltd.!

Placing pharmaceuticals, veterinary products, cosmetics, dietary supplements, food products, and vitamins on the market requires compliance with a variety of administrative procedures. In certain cases, complex documentation must be submitted to the competent authority. ADMA Ltd. organizes these tasks and provides guidance on expected costs and procedural timelines. We undertake the preparation and submission of the necessary documentation.

The authorization procedure is heavily regulated and requires specialized expertise, which is costly to maintain in-house and difficult to justify—particularly for smaller product ranges and sales volumes. Outsourcing authorization tasks is an excellent solution to this problem. ADMA Ltd. takes on these tasks, from the submission of eCTD-format documents to the mandatory license renewals throughout the product's life cycle, including the authorization of manufacturing- and product-related changes, in cooperation with the company's quality assurance function.

Our Services

Pharmaceuticals

Marketing authorization of human medicinal products: MRP, DCP, national, and EU procedures.

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Veterinary

Marketing authorization of veterinary medicinal products, NÉBIH procedures.

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Cosmetics

CPNP product notification, Product Information File (PIF), GMP, cosmetic services.

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Food

Marketing authorization of novel foods, safety assessment documentation.

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Dietary Supplements

OÉTI notification of dietary supplements, preparation of labels and data sheets for market placement.

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XEVMPD

Medicinal product data submission obligations via the EMA EUDRAVIGILANCE system.

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Readability Testing

Readability testing of package leaflets in compliance with statutory requirements, involving at least 20 patients.

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ICSR – Adverse Event Reporting

Electronic reporting of adverse reactions, product complaints, and consumer complaints via the EUDRAVIGILANCE system.

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Curative Products

Reclassification of the curative product category: into a non-prescription (OTC) medicinal product or traditional herbal medicinal product.

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Planning to place a product on the market?
Save valuable time! Our experienced regulatory experts will handle the official procedures and product dossiers for you.

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