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COMPLEX SERVICE RELATED TO THE REGISTRATION OF DRUGS (FINAL DOSAGE FORMS)

  • Expert reports (QOS, etc.)
  • Compilation of the registration dossiers in eCTD format
  • Translation of the texts of product information - SPC, PIL texts and labelling - into national languages performed by pharmaceutical/medical experts
  • Readability test
  • Submission of the dossiers to the National Regulatory Authorities (NRAs)
  • Communication with the NRAs and monitoring of registration procedure,obtaining
    of the final decision (MA)
  • Post-registration service involving variation, renewal and transfer procedures, annual maintenance fees, proofreading of mock-ups, ect.
  • Publicly accessible scientific information service

    Except the Czech Republic we provide this service in the Slovak Republic, Poland, Hungary, Romania, Bulgaria, Slovenia, Latvia, Lithuania, Estonia, Greece. 

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    MD-Pharm Ltd., L. Horke 15/66, 747 21 Kravare, Czech Republic
    Phone: +420 553 671 756, +420 553 671 746, Fax: +420 553 671 746
    E-mail: md-pharm@md-pharm.cz

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