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