Top biotech innovators trust TVT to get
clinical and regulatory content right the first time
Because every clinical hold, rework cycle, and protocol amendment costs you runway
Error-free clinical protocols, IBs, ICFs, submission modules, and investigational product labels, without endless review cycles or document-by-document QC.
These regulatory authorities use TVT to review submissions:
Health authorities and leading biotech companies trust TVT to catch every deviation before it becomes a submission issue.
Other solutions only set your team up for “good enough”
But you need your packaging and documentation to be 100% error-free.
So your team is stuck doing endless rounds of proofreading or drowning in false positives.
Human proofreading
Can easily take up days of your team’s time. Has a high risk of missing text and image deviations, leading to RTFs, clinical holds, or amendment cycles.
Generic text comparison tools
Only work well for simple documents with identical layouts and struggle with different formats or text in complex languages. Can’t handle multi-module eCTD submissions or protocol amendments with redlines spanning hundreds of pages.
Specialized text comparison tools
Have limited configuration options that lead to multiple false positives. Which increases the risk of missing critical deviations during during submission review.
TVT sets the standard for biotech content verification
Automatically comply with regulatory requirements, brand guidelines and country-specific rules.
Catch all deviations, from reading order and text style to brand terms and repeated words.
Automated workflows
Eliminate unnecessary manual work without sacrificing accuracy. Automate error detection for text, images and barcodes.
Configurable settings
Configure project and user settings to match your requirements. So you won't have to deal with false positives.
Built for biotech and biopharma
Comply with ICH E6(R3), 21 CFR Part 11, EU Annex 11, and GCP. Automate audit trails for every document version, from first-in-human protocol to BLA submission.
Become the ultimate champion of “Spot the difference”
Use TVT to spot all discrepancies in clinical protocols, investigator brochures,
informed consent forms, clinical study reports, eCTD submission modules, Module 3 CMC content,
IMP and commercial labels, and patient-facing materials
(Across any combination of these file types: Adobe Illustrator, DOC, HTML, PDF, PPT, XLS and XML, including FHIR)
We never cherry-pick files to make TVT look good.
Send us your most complex files and we'll use them during the demo.
Finally, take 100% accuracy for granted
Glide through your review of all deviations in a single read-through
- Verify scientific nomenclature, including gene and protein names (HGNC), chemical and biologic identifiers, dosage units, and study IDs, with zero tolerance for transcription errors.
- Deploy critical-content checkers for dose strengths, route and frequency, inclusion/exclusion criteria, and adverse event terminology (MedDRA).
- Maintain consistency of terminology across protocols, IBs, ICFs, and submission modules, with custom dictionaries shared across your regulatory, clinical, and CMC teams.
Speed up. Without wondering if you’ve missed an error.
Automate manual steps, from commenting to annotations
- Run one-to-many comparisons across country-specific protocol amendments and translated ICFs for global trials.
- Automatically generate comments for deviations and re-import comments for updated file versions
- Use bulk actions to accept or reject repeated discrepancies across hundreds of pages of protocol or Module 3 content.
Maintain compliance with industry requirements
Reduce the administrative burden while staying compliant
- Easily test TVT in your environment with our validation package
- Generate submission-ready audit trails that hold up to FDA, EMA, and PMDA inspection.
- Configure your report settings, including information inclusion and timestamps
Build a fully compliant process with every step in one place
Prevent submission delays and protocol amendment cycles.
Get signoffs faster and never worry about breaks in your audit trail.
Biotech leaders rely on TVT from first IND through commercial launch
Here’s why they keep using our content comparison software.
There’s more to it than our cute bunny mascot.
“Time savings are astronomical”
Instead of spending up to 8 hours on reviewing labeling, Azurity labeling team can now quickly run and review reports, identifying text changes.
Azurity Pharmaceutical
“It was such a relief to have TVT”
The Dr. Pfleger Medical Information Department team uses TVT to review package leaflets and check for missing spaces in PDF proofs.
Dr. Pfleger Arzneimittel
“The return on investment was achieved within a few months”
After implementing TVT in 2005, Novo Nordisk has started using the solution for large-scale projects involving template changes.
Novo Nordisk
“Now I have more certainty when I sign off a document”
The Regulatory Affairs team can now complete text verification tasks in 15 minutes instead of 12 hours, getting their time back to work on other tasks.
Pharma 5
How is TVT different from other solutions?
We hope we’ve made it clear by now. But if not, find answers below.
Book your demoHow is TVT different from other content verification solutions?
- TVT is used by 20 out of top 20 pharma companies. And it’s the only solution used by all of these health authorities:
- ANSM (French National Agency for Medicines and Health Products Safety)
- MHRA (UK’s Medicines and Healthcare Products Regulatory Agency)
- BfarM (Germany’s Federal Institute for Drugs and Medical Devices)
- EMA (European Medicines Agency)
- HSA (Singapore Health Authority)
TVT helps teams in highly regulated industries automate content verification while staying compliant. It can compare files across different file types, for example, PDF to Word, run one-to-many content comparisons and handle complex layouts, including tables, in all languages that use Unicode Standard encoding.
TVT is configurable, which means that it doesn’t produce high numbers of false positives. It also supports bulk actions and shortcuts, speeding up reviews for TVT power users (and any user that has watched our e-learning video content).
Which compliance regulations does TVT take into account?
TVT facilitates compliance with FDA regulations (21 CFR Part 11) and EMA regulations (Annex 11).
It helps comply with EU 1169/2011, EC 1223/2009, CLP (EC 1272/2008) & GHS, eCFR: 40 CFR Part 156 — Labeling Requirements for Pesticides and Devices, Classification, Labeling and Packaging (CLP) Regulation ((EC) No 1272/2008), and MoCRA.
TVT supports QRD, SPL and SPM submission formats, reading order verification for Section 508 (US) and the EU Accessibility Act, EU Regulation No 1169/2011, FHIR XML documents and improved HTML comparison, as well as a new critical words list for food allergens across Europe and the United States.
Is TVT validated for 21 CFR Part 11 environments?
Yes. TVT is designed for use in regulated environments and supports compliance with 21 CFR Part 11 and similar global regulations (e.g., EU Annex 11).
Key capabilities include:
- Audit trails for all verification activities
- Electronic signatures and controlled workflows
- Validation documentation (IQ/OQ support)
- Secure, traceable handling of regulated content
This ensures your verification processes are inspection-ready and fully compliant.
Does TVT work for protocol amendments and ICF version control?
Yes. TVT is particularly well-suited for managing frequent updates such as protocol amendments and ICF revisions.
It enables:
- Precise comparison between document versions
- Detection of even small but critical changes (e.g., dosage, wording, safety info)
- Consistency checks across related documents (protocol ↔ ICF ↔ submissions)
This ensures that every amendment is:
- Accurately reflected across all documents
- Fully traceable for audits
- Free from unintended discrepancies
Does TVT support eCTD submission documents?
Yes. TVT supports the verification of eCTD submission content by comparing documents across formats and versions to ensure consistency and accuracy before submission.
It can validate:
- Module documents (e.g., clinical summaries, study reports)
- SmPC / labeling content vs submission text
- Updates across submission sequences
This helps ensure that what is submitted to regulators is fully aligned with approved source content—reducing the risk of Refuse-to-File (RTF) issues or costly rework.
What is the difference between the TVT software and the TVT add-ons?
TVT software can help you compare documents across different file formats and detect the following changes:
- word and reading order, including in complex tables
- removed or added text
- changes in images, even for files with different layouts
- style discrepancies, such as text font size and styles
- language-specific formatting issues, such as numbers or date formats
TVT Spelling detects spelling mistakes, while TVT detects text deviations (so if your source file has a typo that’s replicated in other documents, it won’t be recognized).
TVT Artwork is specifically designed for printer’s proof artwork verification. It compares graphics pixel by pixel to catch critical issues like color variations, overprinting or misalignment in packaging or labeling materials.
TVT Barcode can be used to automatically detect, decode, and grade barcodes on packaging or in promotional materials.
Does TVT integrate with regulatory, artwork or document management systems?
Yes! Both on-premise and cloud TVT versions can be integrated into your AMS/DMS and regulatory management systems.
Do you provide support with validating TVT?
Absolutely! Every version of TVT is validated prior to release. For companies that need to validate TVT in their own environment, we provide a validation package with IQ, OQ test cases and a protocol to replicate our own validation process.
Validation takes 1-2 days for most customers.
You can also request validation support from our team.
Do you offer a free trial?
Yes, you can try out TVT for 1 month with all of your team members. You’ll have access to our implementation experts to get tips on using TVT and have your questions answered.
Sign up for a demo so we can set up a personalized walk-through and kick off your trial.
Do you offer training and onboarding support?
Absolutely. TVT comes with comprehensive e-learning and training videos for fast onboarding and GxP compliance. Plus, we offer personalized virtual and on-site training sessions to get your team up to speed quickly.
If you need help, you can always reach out to our customer support team — being able to quickly get actionable tips from our implementation experts is one of the things our customers value most.
“For us, the most important aspect is patient safety”
Pharmanovia switched to TVT to avoid missing errors and to speed up their artwork review
A global lifecycle management healthcare company, Pharmanovia needed to find a way to review documents without multiple reviews and a high risk of missing errors.
“Since implementing TVT, the Regulatory team is a lot more confident in approving an artwork once they have reviewed the report, since they have the 100% security that the text matches whatever is approved by the health authority.”
“We can now create leaflets from scratch using the text files, and 100% know that they match. Now we have a lot more confidence creating from scratch, working directly with the source file.”
Manager, Artwork, Pharmanovia
