eCTD Services

•     eCTD Management
•     Baseline generation

• 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

• e-readyness of documents
• compilation of eCTDs and NeeS
• conversion from paper, NtA or NeeS format to eCTD
• baseline dossier compilation

• Complete eCTD management
• Baseline eCTD preparation
• Dossier reformatting: NtA > CTD and CTD > eCTD

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

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)

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.

•  Document processing
• Full life cycle submission management
• RIMS

• Module 3/2.3 preparation in CTD/eCTD format, in required granularity for eCTD submission
• Creation of EU ‘Baseline Dossier’
• Transformation/re-formatting of legacy chemical-pharmaceutical documentation (e.g. paper/NtA/NeeS -> CTD; CTD -> eCTD)
• Compilation of eCTD dossier (Module 3) – customer to provide access to eCTD document management software