Statistically sound.

Submission process and contact to health authorities

  • Strategic statistical support... 

  • ... in the submission of new products, line extensions, a posteriori submissions
  • ... in the preparation of submission dossiers for health authorities (EMA, FDA)
  • ... in the submission process (Type A, B, C, pre-NDA and pre-BLA meetings with the FDA, scientific advice meetings with the EMA)
  • ... in the approval process (NDA and BLA (FDA), MRP and centralised procedure (EMA), negotiations with authorities, questions and answers)