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We provide necessary support for clients from Europe, USA and Asia (including Russia and CIS countries) for successful approval of biological medicinal products in Europe (EMA, MHRA/UK, MPA/Sweden, AIFA/I): 

  • Contacts with EMA for Marketing Authorization Application
  • Writing CTD for EMA
  • Support for preparing and obtaining Scientific Advice  from EMA
    (Prepare the letter requesting the Scientific Advice, Prepare the Briefing Document)
  • Review of existing documentation
  • Selection of CMO and technology transfer
  • Planning and project management of preclinical and clinical development
  • Gap Analysis (existing documents vs. EMA regulatory requests)
  • Strategic Planning for the Marketing Authorization Application (MAA) in the EU
  • Project Management for the scope of the MAA in the EU
  • Advanced statistical analysis support
  • Data management
  • Assistance in establishing the organization in the EU
  • Act on behalf of the Sponsor during the Centralized procedure with EMA for marketing approval of the Biosimilar
  • Support in requesting Small or Medium size Enterprise Designation from EMA
  • Support in searching for a Importing Partner (importing the drug into the EU)
  • Search for Contract Labs
  • Search for Contract Manufacturing Organization in the EU for manufacturing and release of finished products