eCTDconsultancy

ectd esubmission dmf in ectd ectdconsultancy ema regulatory operations ro ec12342008 grouping regulatory affairs worksharing easmf common european submission portal cessp brexit ectd baseline gdpr electronic drug master file active substance master file asmf drug master file dmf entitity extraction text mining linked data idmp identification of medicinal products structured authoring electronic submissions baseline reformat xevprm psur pharmacovigilance electronic submission adverse drug reactions xevmpd eudravigilance common technical document mah qdossier compliant submissions emea registration ra new variation regulation variations var type