Submission Management

As part of our end-to-end service offering, our expert team can support you to prepare and submit your regulatory applications to the desired Regulatory Agency. Our team will prepare documents in accordance with ICH Common Technical Document (CTD) for medicine application and in relevant IMDRF Technical File formats. With experience in regulatory submissions across several regions, including the Asia-Pacific, North America and Europe, we are ready to support you every step of the way. 

Successful applications have included: 

• New Drug Applications (NDA)
• Category 1 Applications
• Investigational New Drug (IND)
• Investigational Device Exemption (IDE)
• Biological License Applications (BLA)
• Generic/Biosimilar medicine applications
• Device/IVD Pre-Market Approval (PMA)
• Orphan Drug Designations (ODDs)
• Clinical Trial Applications (CTA)

• Quality or Clinical variations
• Self-assessable notifications
• Annual Reports