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Pharma-EU, s.r.o. provides superior levels of service to pharmaceutical regulatory affairs professionals in the European Union.

Pharma-EU, s.r.o. complies with all EU national agencies and EMEA.

Commitment to Quality:

Pharma-EU’s team of consultants is committed to providing the highest quality levels of service.

Services Offered:

• Readability testing of PILs (Consultations with users about package information leaflets)
  • Quality user testing guaranteed to be accepted by all European Health Agencies
  • Complete testing to comply with the requirements within 4 weeks
  • PIL revisions to achieve passing result
  • The end result is a high quality PIL
• PIL Services
  • PIL writing
  • Updating of PILs to QRD format
  • Translations of PILs to all European languages
  • Quality control of translated PILs
• Sourcing and translating SmPCs to all European languages
• SmPC comparison for MRP/DCP
• Dossier compilation

Professional in-company training for package information leaflets

The new regulatory environment of the EU is focused on reforming package information leaflets across Europe. To meet these challenges, you will need associates who can write high quality PILs. To meet the demand, we have created a one day comprehensive training course on how to best write PILs.

Please do not hesitate to contact us with any questions or for a free consultation.