Mono eCTD Office

Suite of integrated software products for the creation, manipulation, validation, publishing and viewing of NeeS / VNeeS / eCTD electronic submissions.

[Mono eCTD Office @ectdoffice]

🚀 Mono eCTD Validator now supports eCTD v4.0 validation for both the US (FDA) and EU (EMA).

Validate your eCTD 4.0 regulatory submissions with the same fast, multi-regional validation platform.
https://t.co/LL1ZhL68oR

#eCTD #eCTDv4 #FDA #EMA #RegulatoryAffairs #eSubmission

[Mono eCTD Office @ectdoffice]

How💖 healthy is your #eCTD product?
Are you confident the entire lifecycle is valid?
eCTD Product Validation processes all sequences and performs most important checks related to the validity of content, lifecycle and checksum matching.
https://t.co/cZXkhLUOJX

[Mono eCTD Office @ectdoffice]

📣New milestone reached! Are you ready for #eCTD v4.0 ?
Mono eCTD Viewer ➡ first eCTD reviewing solution to support eCTD 4.0!
Context Of Use lifecycle, controlled and defined keywords, studies, document types, documents, hyperlinks ... all covered.
https://t.co/cZXkhLUOJX

[Mono eCTD Office @ectdoffice]

📣 Release announcement: *full support* and compliance with UA (#Ukraine SECMOH) #eCTD Module 1 implemented in Mono eCTD Office (publishing), Mono eCTD Validator (technical validation) and Mono eCTD Viewer (reviewing).
https://t.co/YHj6kCyhYF Are you prepared for test period?

[Mono eCTD Office @ectdoffice]

Prior to filing your #eCTD submissions to #regulatory agencies you should make certain your sequences are technically valid. ✅ Mono eCTD Validator is the fastest multi-regional eCTD validation solution. Listed in CESP, suggested by TGA. Try today!
https://t.co/LL1ZhL68oR

[Mono eCTD Office @ectdoffice]

❔ Trying to use Edge, Chrome or Internet Explorer to view #eCTD backbones? Internet Explorer is no longer supported and using a browser to navigate #XML backbones could be cumbersome ❕
🗯 Looking for a true *eCTD navigation and reviewing* system? https://t.co/cZXkhLUgUp ✔

[Mono eCTD Office @ectdoffice]

📑 Reviewing changes in your latest #eCTD sequence? Document has been replaced and you need to find changes?
👉 Using Mono eCTD Viewer's (https://t.co/cZXkhLUgUp) "Compare Documents" identify differences by comparing two versions of a document: lifecycle replacement and original.

[Mono eCTD Office @ectdoffice]

@DivneshKumar Hi Divnesh, please contact us via our contact page and we'll go into any details on our eCTD Viewer you'd like to know. https://t.co/qbqV4kEEt3

[Mono eCTD Office @ectdoffice]

Thinking of how fantastic would it be if you could search all your #eCTD product's documents for a *specific word or a phrase*?
🔎 Locate all documents mentioning 'dosage form' in sequence (/regulatory activity) 0001?
✅ Using Mono eCTD Viewer: https://t.co/cZXkhLUgUp
Try today!

[Mono eCTD Office @ectdoffice]

💭 Having issues following recent #FDA study data #eCTD submission requirements?
🎯 Our *Simplified TS Generator* ensures technical compliance for your SDTM/SEND datasets.
📣 *XPT Browser* will scan your submission for #xpt files and display tabular data.
https://t.co/YHj6kCyhYF

[Mono eCTD Office @ectdoffice]

Having trouble viewing #XPT data in #eCTD submissions?
Our XPT Viewer quickly parses electronic datasets and presents data in a user-friendly format.
Readily check if the study start date is defined. Make sure StudyID (or SPREFID) matches STF's StudyID.
https://t.co/cZXkhLUgUp

[Mono eCTD Office @ectdoffice]

👉 Ready to review the lifecycle of Chinese #eCTD submissions for the NMPA/CDE?

IND (临床试验申请), NDA (新药申请) or ANDA (仿制药申请)? Chemical (化学药品) or Biological (生物制) product?

We have it all covered in our
✔ Mono eCTD Viewer: https://t.co/cZXkhLUgUp

[Mono eCTD Office @ectdoffice]

(Re-)viewing an #eCTD sequence?
Streamline your internal reviewing process using standard #PDF markup annotations.
Easily summarize comments in documents and share with the team.
Your documents (and backbones) are not altered in any way!
A feature of https://t.co/cZXkhLUgUp

[Mono eCTD Office @ectdoffice]

The wait is over 🙂
Mono eCTD Validator is a free*, super-fast, stand-alone, easy to use Windows desktop application for the technical validation of electronic submissions / regulatory transactions prepared in the #eCTD format.
https://t.co/WgWcHO5UYV

[Mono eCTD Office @ectdoffice]

Hundreds of #eCTD sequences? Thousands of document? Millions of PDF hyperlinks?

We have redefined the meaning of "streamlining #regulatory review/QC process" in Mono eCTD Viewer and Mono eCTD Office.

https://t.co/sNg1a4FJUD
https://t.co/6XKfdsuev7

[Mono eCTD Office @ectdoffice]

As we are all learning how to navigate our daily tasks through the #COVID19 time, we send a warm message to our clients and partners: stay home and stay well. Our #ectd support is just one safe email away. @ectdoffice supports both client and server install with remote access.

[Mono eCTD Office @ectdoffice]

Uooops #DIAEurope2020 is postponed - no biggie - see you @ C2 in July :) And, of course: https://t.co/sNg1a4Xljd

[Mono eCTD Office @ectdoffice]

Only ~1 mil secs till #DIAEurope2020. When you get tired from collecting booth goodies and from all the life science talk: pharma this, coronavirus that -> stop by C2 to relax and we'll chat about something completely different! No, do not ask us how to https://t.co/6XKfdscDDz

[Mono eCTD Office @ectdoffice]

Only two months to go! We're excited to be exhibiting at #DIAEurope2020. If you are into #eCTD, don't miss our "see too" booth :) Visit us at #C2 to say "hi" and forge new partnerships. 17-19 March 2020 in Brussels. https://t.co/cJjRcqtNr4
https://t.co/sNg1a4Xljd

[Mono eCTD Office @ectdoffice]

Mono @ectdoffice experts held a practical, hands-on, CTD and #eCTD training in #Amman, #Jordan. Topics ranging from what is eCTD and how get prepared for electronic submission to how to solve most common validation issues using real-world scenarios.