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Dossier Preparation and Regulatory Procedures Management

Regulatory Pharma Net

RPN staff has wide experience in the preparation of registration dossier and management of the relevant procedures (marketing authorisation applications, variations and renewals).

  • Support for the preparation of registration dossiers including critical sections (e.g. pharmacovigilance system master file, risk management plan, environmental risk assessment)
  • Advise on different requirements for the submission of marketing authorisation applications (e.g. number of paper copies, electronic submission, content of module 1 etc.)
  • Assistance in writing response documents to authority deficiency letters/list of questions
  • Assistance in updating dossier sections in response to authority deficiency letters during marketing authorisation procedures
  • Preparation of CTDs
  • Preparation of eCTD or NeeS submissions
  • Management of e-submissions, whether eCTD or non-eCTD electronic submission (NeeS)
  • Assessment of eCTD or NeeS applications for compliance prior to submission
  • Preparation, submission and management of variation, renewal and MA transfer applications
  • Preparation, submission and management (through local agent) of application procedures in USA: IND, NDA, ANDA
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