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)