European - EMA Services
The recent mandate from EMA is that no paper submission should be submitted to any regulatory agency within EU after January 1, 2010 for the centralized Procedure that includes EMA, Rapporteurs and all CHMP members.
The PharmaReady eSubmissions team carries extensive experience in providing eSubmissions consulting for any submission made in the context of a centralized application procedure and the subsequent maintenance of the lifecycle of the application including:
- Initial application
- Supplementary information
- Follow-Up Measures (FUMs)
- Periodic Safety Update Reports (PSURS)
Any eCTD submission submitted to EMA should be checked for Technical and Business Validation conformance. The PharmaReady eSubmissions team is well versed with checking the correctness of the eCTD submission from both technical (using automated validation tools) and business perspectives (a thorough Quality Analysis performed by in-house scientific and Regulatory Affairs consultants).
Submissions MilestonesThe PharmaReady eSubmissions team can help customers to meet the key milestones as outlined below in a typical market authorization procedure.
- 1. Initial submission (Day 0 of procedure)
- 2. Response to business validation issues (if required)
- 3. Response to List of Questions (i.e. Day 121 for a new application)
- 4. Response to List of Outstanding Issues (i.e. Day 181, if required)
- 5. Application as agreed at Opinion (i.e. agreed EN product information if changed at
- 6. Provision of translations (i.e. Day 215 for a new application)
- 7. Provision of final agreed translations following linguistic review (it is not also required to
send interim working versions of the product information before this point as eCTD)
- 8. Decision (i.e. final amended documentation if any changes occur during the Standing