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Qdossier

 

 

Qdossier is using Samarind RMS as its in-house XEVMPD tool.

Qdossier has successfully implemented Samarind RMS on its servers. Qdossier, a sister Company of eCTDconsultancy, uses Samarind RMS as in house tool for the build and maintenance of Marketing authorization holder’s (MAH) xEVMPDs as a Service. The tool creates both initial and lifecycle xEVPRMs. Qdossier already partners with various MAHs to:

  1. collect data and SPCs
  2. pragmatically solve issues not yet or unambiguously addressed by the EMA
  3. enter and check data and SPCs 
  4. create valid messages for submission to the EMA.

Qdossier’s procedures are well documented and tuned to efficient xEVMPD data entry and future lifecycle, thereby optimally using the features of Samarind RMS.

Since Samarind RMS is implemented in a SaaS environment, MAHs can access their own data for final QC and subsequent retrieval of registration statuses.

Together, Samarind RMS and the services provided by Qdossier procedures have proven to be easily scalable and quickly adoptable by new users.

Qdossier has already many years of practical experience within the field of electronic submissions and data management (Regulatory Operations) and can leverage from their experience with handling eCTDs, eDMS and RIMS systems.

For further information please contact Qdossier directly.