Dossier Preparation and Regulatory Procedures Management

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