Registration of pharmaceuticals

Armedika the registration and introduction of new medicinal products, food supplements, medical devices and cosmetics in the Baltic countries and CIS countries and rest of Europe.

ARMEDIKA are natural product regulatory compliance experts specializing in Baltic countries and European Union (EU) nutritional food, supplements, medicines and cosmetic laws.

  • Registration of new pharmaceuticals (national, DCP and MRP procedures);
  • Renewals of marketing authorisations;
  • Pre submission Assessment and Consulting;
  • Experienced external experts provide a critical assessment of the dossier identifying any weak points and proposing appropriate solutions;
  • Regulatory submissions of RSUP;
  • Documentation for applications, renewals and variations are prepared in accordance with national requirements and applicable EU guidelines;
  • Type IA, IB, II variations and other non-variation changes;
  • Change of the classification of a medicinal products (OTC/prescription);
  • Pharmacovigilance;
  • Package Leaflet (PL) Readability User testing;
  • A dedicated and trained team performs full readability user testing or prepares bridging strategies for your product portfolios;
  • Preparation of authorization documents;
  • Development of regulatory documentation;
  • We prepare clinical/nonclinical summaries and overviews compatible with CTD format.
  • Electronic submissions;
  • We offer the creation, validation, viewing, manipulation, archiving and publishing of NeeS / eCTD submissions to the regulatory authorities;

ARMEDIKA are borderline grey area specialists with significant regulatory and scientific understanding of botanical ingredients.
We can tell you if your products are viable for an EU traditional herbal medicinal product license and complete common technical document (CTD) dossiers for traditional herbal registration (THR) license applications.

Contacts:
General inquiries: reg@armedika.lt

Services in Lithuania, Latvia, Estonia and other EU countries :
Contact person: Augusta Ževžikovienė
E-mail: augusta.zevzikoviene@armedika.lt
Cell phone: +370 688 81118

Services in Belarus, Russia and Kazakhstan:
Contact person: Aras Tarabilda
E-mail: reg@armedika.lt
Cell phone: +370 (685) 20002

If you have an interest to have common business with our company and have some questions, please don’t hesitate and feel free to ask.