eCTD Dienstleistungen

• eCTD Management
• Baseline Erstellung

• eCTD Service inklusive Erstellung von Baseline eCTDs
• Umformatierung von Zulassungsdossiers (NtA in CTD Format bzw.CTD in NeeS und eCTD-Strukturen)

• Kompilieren des Arzneimittel Dossiers in das electronic Common Technical Document [eCTD] Format für die elektronische Einreichung

• Co-ordination of e-CTD initiative, baseline compilation and variation packages
• Compilation of Baseline dossiers

• Validate and select your software
• Compile eCTD and NeeS submissions
• Transition from paper to eCTD
• Prepare electronic submissions

• Komplettes eCTD Management
• Baseline eCTD Erstellung
• Umformatierung von Dossiers: NtA > CTD und CTD > eCTD

• e-Readyness von Dokumenten
• Erstellung von eCTDs und NeeS
• Umwandlung von Papier-, NtA and NeeS-Format zu eCTD
• Erstellung von Baseline Dossiers

Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.

• Dossiercomplilation in customer databases or own
• Data Management & IDMP

Unsere Leistungen: 

• Erstellung, Validierung und Einreichung des Zulassungsdossiers im eCTD-Format
• Umformatierung in eCTD
• Erstellung einer eCTD Baseline
• Pflege des eCTD-Dossiers im Life Cycle Management
• Digitalisierung der Papierdokumente

ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic.  

• Compilation, submission and coordination of eCTD dossiers (EU, US, Australia), e.g. MAA, IND, BLA, NDA, DMF, ASMF etc.
• Preparation of eCTD baseline submissions
• Compilation of NeeS dossiers
• eCTD life-cycle management, including post-approval variations, amendments etc.
• Preparation of eCTD ready documents and PDF files