Regulatory Submissions

Accelagen have prepared and submitted a large variety of regulatory applications, including:

• New chemical or biological medicines
• Generic applications
• Device/IVD Inclusion Applications
• Orphan Drug Designations (ODDs)
• Investigational New Drug (IND) applications
• Investigational Device Exemption (IDE) applications
• Quality or Clinical variations
• Self-assessable notifications
• Annual Reports
• Clinical Trial Notifications

Accelagen have developed various templates to prepared documents in accordance with ICH Common Technical Document (CTD) for medicine application and the IMDRF Technical File formats.