Our services

We are a team of pharmaceutical experts offering tailored made services focused on but not limited to:

• Regulatory service
  • preparation and update of registration documentation
  • regulatory support within EU in line with your company requirements
  • new application submissions (DCP, MRP and NP) and communication with competent authorities
  • Life-cycle maintenance
  • preparation and update of local translations of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling (LAB)
  • artworks maintenance
  • monitoring of local legislation

• eCTD compilation
  • complete eCTD maintenance of your product portfolio

• EU Batch Release site
  • GMP-certified importation, batch testing and batch release services
  • communication with contractual Batch testing laboratory
  • archivation of reference and retention samples
  • maintenance of GMP/GDP documentation
  • Product quality review reports preparation (PQR)

• GMP/GDP SOP preparation, implementation of global SOPs into local ones

• Market Access
  • full complex support for Czech republic from registration to distribution
  • price & reimbursement management including the related administrative proceedings
  • coordination of price-patient payment processes required for introducing a medicinal product into market