eRegulatory Affairs

• cune-IDMP: Regulatory Master Data Management for xEVMPD and IDMP compliance that includes seamless access to external systems such as GSRS, UCUM and EDQM
• cune-RDMS: Cunesoft’s Regulatory Document Management Software helps you keep track of all of your submission-related documents
• cune-eCTD: Prepare and compile eCTD’s, NeeS, VNeeS, and paper CTD’s all in one place with our eCTD submission software
• cune-RIM: Intelligent Regulatory Information Management solution
• cune-Distiller:
  o   Extract data from submission documents, SmPC’s & xEVPRM’s
  o   Automatically maps MedDRA, GSRS, WHO codes
  o   Generate IDMP ready data

 Michor Consulting can help you:
   o Advise on appropriate software 
   o Help with software selection 
   o Determine user requirements 
   o Write SOPs 
   o Train Personnel 
   o Guide and coordinate software installation and validation via suitable vendors 

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)