Time in

Vilnius, Tallinn, Riga

Regulatory Affairs

We are providing services related to:

  • Marketing authorisation of medicinal products (via national, decentralised and MRP procedures)
  • Renewal of marketing authorisation of medicinal products
  • PSUR submission
  • Type IA, IB and II variations
  • Non-variation changes
  • Change of the classification for the supply of a medicinal products
  • Approval of additional labells (stickers)
  • Approval of marketing material
  • Notification of food supplements

Additional services :

  • Preparation of package leaflet according to SPC and/or readability guidelines
  • Package leaflet user testing for readability

Consulting regarding:

  • Requirements and possibilities for medicines authorisation (eg. medicines, registered in other EU countries, registration via national procedure)
  • Medicines repackaging
  • Choise of partners for distribution
  • Choise of partners for medicines and food supplements marketing and sales activities
  • Professionalism.
    We are specialists in this field and like our activity, so we can guarantee the quality of our work.
  • Competitiveness.
    Individual solutions for a competitive price.
  • Confidentiality.
    We appreciate the cooperation, maintain confidentiality and seek for a long-term partnership

Member of Medicines Manufacturers Association