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Management of Regulatory Procedures and dossier preparation

Assion services are:

  • Support for the preparation of registration dossiers in eCTD format including critical sections (e.g. Pharmacovigilance System Master File, Risk Management Plan, Environmental Risk Assessment)
  • Advise on different local requirements for the submission of applications
  • Management of the regulatory procedures (EU, US and worldwide) 
  • Assistance in preparing and attending oral hearings with the authority before and during procedures
  • Assistance in writing response documents to authority deficiency letters/list of questions
  • Assistance in updating dossier sections in response to authority deficiency letters during the registration procedures

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On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.