Regulatory Affairs Services

We are providing regulatory affairs services:

  • Marketing authorisation of medicines (via national procedure, DCP and MRP)
  • Renewal of marketing authorisation of medicinal products
  • Type IA, IB and II variations
  • Change of the classification for the supply of a medicinal products
  • Article 61(3) changes
  • PSURs submission
  • Approval of additional labells (stickers)
  • Approval of marketing material
  • Notification of food supplements, foods for special medical purposes

Additional services :

  • Medical writings
  • Pharmaceutical writings
  • Artworks design

Consulting regarding:

  • Regulatory strategy
  • Medicines repackaging
  • Market access
  • Pricing & Reimbursement

Coverage of the Territories:

CEE countries, including:

  • Baltics (Estonia, Latvian & Lithuania)
  • Poland
  • Hungary
  • Bulgaria
  • Romania
  • Other
  • 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