Regions  

Submission

Our submission services include a wide variety meeting the global regulatory standards and requirements.

  • Orphan Designations
  • Paediatric Investigation Plans (PIPs) Centralised Decentralised
  • Clinical Trial or Investigational New Drug Applications – CTA/IND
  • Invitro/CDX
  • Marketing Authorisation or New Drug Applications – MAA/(s)NDA/(s)BLA/ANDA
  • Biosimilar Submissions
  • EU Centralised, Decentralised, Mutual Recognition Procedures
  • EU CHMP, PRAC and CMD(h) Referrals
  • EU Small, Medium Enterprise (SME) Status
  • Scientific Advice or Pre-Phase III Health Authority Interactions
  • Label/Safety Updates
  • Marketing Authorisation/License Renewals