Consultancy
Document Management Strategy
Do you consider your R&D / Submission Documents among the core assets of the company?
If not, think again - these documents constitutes much of the science you do and conveys the storyline from your company to the authorities, paving the way for your company, to allow for clinical trial execution and eventually marketing authorization.
With a systematic and structured approach you can obtain full control over this aspect of your asset via a Document Management Strategy.
Due Diligence - Buyer
Are you about to investigate another company through a Due Diligence process we can help quantify and qualify the risk aspects of the R&D asset documentation.
After all, even groundbreaking science won’t get to the patients - if it isn’t documented adequately.
The current state of the asset documentation
What it requires to achieve a “ready-to-submit” eCTD compliant state
Document Integrity assessment
Asset Documentation Risk Profiling, how the documentation has been managed can affect the integrity and limit future use
Due Diligence - Seller
If your company is the subject of a Due Diligence we can help you present your R&D assets in justified light they deserve. We can not inflate the value of your science - but we can make sure that the true value is reflected and not obscured by messy documentation, uncontrolled redundancy, illegal formats and lack of submission readiness.
Consider this a directly value adding exercise to traditional Due Diligence preparation.
Format Review (of Word files)
Ensures eCTD compliance of MS-Word documents prior to approval/rendering in EDMS system
Training
Training of company staff in eCTD authoring techniques, submission readiness and issue troubleshooting
Data Privacy
Redaction/removal of personal data in documents (PII / CCI)
Digitization (to eCTD)
Conversion of analog (paper) documents, instrument output or analog specimen to eCTD compliance
Document Migration
Transfer of legacy documents to documizer™ templates
Style Guides
Client specific style guides for aligned and consistent authoring
Document Processing (of PDF files)
Ensures best achievable eCTD compliance of already approved “legacy” PDF files
PDF Task Force
Occasionally a document can be VERY difficult to render to an eCTD compliant PDF. The Documizer PDF Task Force is here to help - with an array of various tools and expertise we guarantee that ANY document will have its corresponding PDF rendition no matter how big or technically complex the document is.
Author Support
Resolution of document issues and technical author support.
Hypercare
Prioritized “on-duty” document troubleshooting for mission-critical / pre-submission support.
Custom Templates
Prioritized “on-duty” document troubleshooting for mission-critical / pre-submission support.