Find software providers for regulatory affairs software from eCTD, xEVMPD and IDMP to regulatory affairs databases or automated proofreading solutions. The list does not claim to be complete and no guarantee can be given for the correctness and timeliness of the information provided. Furthermore, please note that this list does not have any recommendatory character.
If you are a provider of regualtory affairs software, you have the possibility to register free of charge in this directory.
Michor Consulting and Trade Services GmbH
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.