RANGE OF OUR SERVICES OUTSIDE UE:

  • Consultation advice on the assessment of the potential registration of products in specified markets.
  • Carry out a full registration process in the relevant state authorities - registration of drugs, food supplements, medical devices and cosmetics.
  • Carry out of post authorization variations including change in the Marketing Authorization Holder (responsible entity).
  • Carry out renewals.
  • Consultancy on country specific requirements and professional help with:
    • preparation of registration and variation applications,
    • compilation of registration dossier/variation documentation  adapted to the current state requirements,
    • preparation and translation of Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL), labelling,
    • getting notarially certified translation of official documents and if necessary, we deal with obtaining classified documents apostille certificates,
  • Support for communication with the competent authorities in the registration including help in making contract registrations.
  • Assist in preparation of responses to formal letters and expert questions.
  • Support in obtaining permits for import of samples for testing.
  • Support in conducting Clinical Trials in the country, where there are indications from the national authority.
  • Service of monitoring of adverse drug reactions in the country  registration field (Pharmacovigilance).
  • Submission of periodic safety update reports (Periodic Safety Update Report - PSUR).

We encourage you to contact us.

Export

As exporters, we operate mainly (but not exclusively) on Asian (Vietnam, Kazakhstan) and both Central and Eastern European (Poland, Hungary, Ukraine, the Czech Republic, Belarus, Bulgaria and many other) markets. We provide comprehensive support for foreign transactions, as well as a reliable and stable level of sales..