Efficient coordination & comprehensive eCTD Publishing and Submission services for pharmaceutical applications worldwide.
- Original ANDA (Abbreviated New Drug Application)
- Original NDA (New Drug Application)
- Original IND (Investigational New Drug)
- Original BLA (Biologics License Applications)
- Original DMF (Drug Master File)
- Original ANDS (Abbreviated New Drug Submission)
- Original NDS (New Drug Submission)
- Initial MAA (Marketing Authorisation Application)
- Initial CEP (Certificate of Suitability)
- Initial ASMF (Active Substance Master File)
- Pre-Approval Amendments (Information Request, Complete Response, Discipline Review Letter, Validation Response)
- OPDP Ad-Promo Submission
- IND Safety Report
- CMC Supplement
- Labeling Supplement
- Efficacy Supplement
- Annual Report
- PADER/PSUR
- Renewal
- Variations
- Extension
- Product Correspondences
- Withdrawal
- Clinical Trial Application (CTA)