PHARMEDIAN

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Our offer

Comperhensive service for placing the product on the Slovak market – human and veterinary medicines, medical devices, food supplements and cosmetics.

  • years of experience in the field
  • expertise and professionalism
  • reliability and ethics
  • individual approach
  • flexible and action dealing
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Our services

Wide range of activities that meet general conditions for obtaining a registration decision.

Our service replaces the need of internal specialist, in optimal cooperation with the producer/MAH guarantees quality and fast action.

Humane and veterinary drugs

  • preparation of AFs, national documents, evaluation of the registration dossier before submission
  • communication with national authorities – ŠÚKL, ÚŠKVBL
  • submission of variations, extensions, transfers, renewals
  • renewal of the registration
  • transfer of the registration
  • monitoring the registration process
  • professional translation of texts (SPC, PIL, labelling) from English to Slovak language
  • review of mock-ups
  • administrative service
  • archiving of relevant documents

Medical devices

  • preparation of AFs, national documents and evaluation of the registration documentation
  • communication with national authority – ŠUKL
  • submission of variations, extensions, renewals
  • monitoring the registration process
  • professional translation of texts required for MDs
  • review of labelling and instructions for use
  • monitoring of amendments in the legislation (EU,SK), immediate application to daily practice

Food supplements

  • preparation of AFs and evaluation of documents before notification
  • communication with national authority – ÚVZ SR
  • submission of variations, renewals
  • professional preparation and translations of texts
  • review of texts before marketing
  • monitoring of amendments in the legislation (EU,SK), immediate application to daily practice

Additional services

  • translation of various professional marketing materials with its immediate incorporation into original print or other artworks
  • complete print and web graphics

Company profile

PHARMEDIAN s.r.o. was established in 1999 as an integrated part of the structure of Swiss company Medial AG in the countries of Central Eastern Europe.

Medial AG has represented companies which were not adequately presented in the area, and provided all regulatory and marketing activities according to the requirements of their partners.

In 2005 PHARMEDIAN s.r.o. changed its entity and continued as an independent company with the same scope of activities, from 2011 focused mainly on regulatory processes.

Our partners

  • 3M Slovakia
  • Westcor
  • OM PHARMA
  • BIONICHE
  • BIOLITEC
  • OXOID
  • TORREX
  • GRUNENTHAL
  • DR. FALK PHARMA
  • CEVA Animal Health Slovakia
  • UCB Pharma
  • Liftec CZ

Contacts

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