National Marketing Authorization Applications
Decentralised, Mutual Recognition, National Procedures
We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing Authorisation procedures of medicinal products via Centralised, Decentralised or Mutual Recognition procedures.
We provide full-scope service of procedure management, starting from the booking of a slot for Decentralised or Mutual Recognition procedures, dossier development, pre-submission assessment, eCTD compilation and submission to competent authorities, support in preparing responses to deficiencies reported by the Competent authorities, full support during CHMP and CMDh referral procedures, until the granting of Marketing Authorization.