MA files in CTD & eCTD formats, Procedures, Variations

WHITE-TILLET advises and assists you in:

  • Preparing modules 1 and 2 (including 2.3,2.4,2.5,2.6, and 2.7);
  • Realizing your CTD file;
  • Realizing your eCTD (constitution, validation, acceptability);
  • Establishing and following-up of procedures: centralized, DCP, MRP, national, blue box;
  • Assisting with the Competent Authorities: EMA or national in Europe;
  • Requesting the establishment of specific procedures: conditional MA, accelerated procedures, SME;
  • Realizing the files and the management procedures for the orphan drugs;
  • Modifying  your MA files

Tillet Y et Maillols-Perroy A.C. Orphan Drugs in Europe: an opportunity for developers. Thérapie 2015 Juillet-Août; 70 (4): 351–357

Contact

+33 1 60 08 43 85
+33 1 60 08 00 22

24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France