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

ProPharma Group GmbH 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 

DocShifter is a software solution that takes all your digital content (Office documents, images, PDF, etc.) and transforms it into technically compliant PDF (for FDA, EMA, PDMA, etc.). Do you need format transformations in the context of submissions, data or document migration, digital archiving, correspondence management or data extraction for IDMP?

We connect to all your enterprise systems for document management, regulatory information management, quality management and many more. Centralizing this process ensures harmonization, reduces risk and cost.

File transformations include but are not limited to: PDF, PDF/A, Word, TIFF, JPEG. DocShifter transforms thousands of documents 10x faster and at higher quality than comparable solutions. Speeding up your submission process.

• Create fully technical compliant PDF's for any region (FDA, PMDA, EMA and many more)
• Extensive document enrichment: PDF merging, font embedding, hyperlinking, splitting, pagination, watermarking, header & footer, advanced bookmarking and much more. 
• Automate correspondence tracking by harmonizing all incoming communication with health authorities.
• Automating form completion
• Fast (no need for native applications). 
• Reduced TCO. Lower licencing & infrastructure costs.
• Neutral. Connect all your enterprise applications (DMS, RIM, etc.) and centralize.
• Simple. Easy to use, implement and maintain.
• Runs on all platforms (Docker, UNIX, Windows)

• Erstellung von Baseline eCTDs
• Erstellung von eCTDs und NeeS
• Umwandlung von Papier-, NtA and NeeS-Format zu eCTD
• Erstellung, Validierung und Einreichung des Zulassungsdossiers im eCTD-Format 
• Digitalisierung der Papierdokumente 

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Bearbeitung von Dokumenten zur eCTD Einreichung
• Durchführung elektronischer Einreichungen aller Produktstationen
• RIMS