Regulatory Open Forum

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Hi Brittany,
We use DocuBridge from Lorenz.
I suggest you make a list of requirements first, such as:
-budget
-cost of software licence + cost of  each sequence publishing
-access to software (on a server, or on a local PC or laptop)
- users (one at a time, multiple at different times or multiple at the same time)
- use it yourself or have a publisher do it for you.
There are quite a few Indian companies that do this now and you have the advantage of time shift if they do it for you.
The "down side" (depending on how you look at it) is that you will need to share the data with the publisher.

Feel free to contact me directly if you want more information.
Good luck!

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
------------------------------

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Hello - we have helped 100's of companies, small and large, with eCTD submission publishing and would love to connect with you to discuss your needs.  Please reach out any time.

.https://www.veeva.com/products/vault-submissions-publishing/

------------------------------
Terri Howard RAC
Director, Strategy, Medical Device & Diagnostics
Pleasanton CA
United States
------------------------------

Original Message:
Sent: 24-Oct-2019 09:12
From: Sorin Alb
Subject: eCTD Software Recommendations

Hi Brittany,
We use DocuBridge from Lorenz.
I suggest you make a list of requirements first, such as:
-budget
-cost of software licence + cost of  each sequence publishing
-access to software (on a server, or on a local PC or laptop)
- users (one at a time, multiple at different times or multiple at the same time)
- use it yourself or have a publisher do it for you.
There are quite a few Indian companies that do this now and you have the advantage of time shift if they do it for you.
The "down side" (depending on how you look at it) is that you will need to share the data with the publisher.

Feel free to contact me directly if you want more information.
Good luck!

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

I'm looking as well, but since we're a tiny company where is be the only user and do less than 10 subs per year, I need something super low cost. 

Am thinking that a fee per model would be best for now.  Any suggestions?  What are the key issues for this option?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Please remember the adage "you get what you pay for".
Take a look at the Lorenz store
https://www.lorenz.cc/Store/

Full disclosure, I am not paid by Lorenz to advertise their product.
I am talking about it because I am working with it, and I know that Health Canada is using it for review of the eCTDs.

The price for the  software licence seems reasonable, but you need to remember that you pay for the publishing of each sequence (one token each time).
If you submit to multiple markets, I think you need a separate licence for each market, but I could be wrong.
I would suggest to have a chat first with their sales person in your country, if there is one.
Here is the contact info:
https://www.lorenz.cc/Contact/

Maybe you should contact Medsafe to ask them if they have any preference...
Just my two cents.
Hopefully this helps.

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
------------------------------

Original Message:
Sent: 25-Oct-2019 15:22
From: Tina O'Brien
Subject: eCTD Software Recommendations

I'm looking as well, but since we're a tiny company where is be the only user and do less than 10 subs per year, I need something super low cost.

Am thinking that a fee per model would be best for now.  Any suggestions?  What are the key issues for this option?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Thanks for that info!  This might be doable since the types of device submissions I need for Canada and Australia aren't currently accepted as electronic submissions but as NeeS, so the tokens are not a concern.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 25-Oct-2019 15:45
From: Sorin Alb
Subject: eCTD Software Recommendations

Please remember the adage "you get what you pay for".
Take a look at the Lorenz store
https://www.lorenz.cc/Store/

Full disclosure, I am not paid by Lorenz to advertise their product.
I am talking about it because I am working with it, and I know that Health Canada is using it for review of the eCTDs.

The price for the  software licence seems reasonable, but you need to remember that you pay for the publishing of each sequence (one token each time).
If you submit to multiple markets, I think you need a separate licence for each market, but I could be wrong.
I would suggest to have a chat first with their sales person in your country, if there is one.
Here is the contact info:
https://www.lorenz.cc/Contact/

Maybe you should contact Medsafe to ask them if they have any preference...
Just my two cents.
Hopefully this helps.

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada

Original Message:
Sent: 25-Oct-2019 15:22
From: Tina O'Brien
Subject: eCTD Software Recommendations

I'm looking as well, but since we're a tiny company where is be the only user and do less than 10 subs per year, I need something super low cost.

Am thinking that a fee per model would be best for now.  Any suggestions?  What are the key issues for this option?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Avalis in CO may be a good resource.  We use them for facility conversions and submissions, for 4-6 submissions per year.

Facet also provides services, if you don't want to bring in-house.  And for a lot of smaller organizations, outsourcing the RegOps may be a cost savings.
Original Message:
Sent: 25-Oct-2019 15:22
From: Tina O'Brien
Subject: eCTD Software Recommendations

I'm looking as well, but since we're a tiny company where is be the only user and do less than 10 subs per year, I need something super low cost.

Am thinking that a fee per model would be best for now.  Any suggestions?  What are the key issues for this option?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Hello Brittany and Tina,

I am in the same situation as you guys. I have done my research and I agree with Sorin before searching for a publishing platform (web or software based) it is better that you answer yourself such questions as:
- what is the budget
- how many people from your organization will utilize that publishing tool
- how many submissions are intended to be published during the year
- what are the regions you are submitting to etc.

I have reached out to many companies (CuneSoft, master Control Lorenz etc... and for small companies with one publisher I think DocuBridge software is the best case scenario (in terms of budget). It can all get more complicated with any changes in value of the bullet points mentioned above.

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
------------------------------

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

I would add to Arthur's list:
- filing only one category (drugs) or more (drugs and medical devices)

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
------------------------------

Original Message:
Sent: 29-Oct-2019 10:32
From: Artur Shchukin
Subject: eCTD Software Recommendations

Hello Brittany and Tina,

I am in the same situation as you guys. I have done my research and I agree with Sorin before searching for a publishing platform (web or software based) it is better that you answer yourself such questions as:
- what is the budget
- how many people from your organization will utilize that publishing tool
- how many submissions are intended to be published during the year
- what are the regions you are submitting to etc.

I have reached out to many companies (CuneSoft, master Control Lorenz etc... and for small companies with one publisher I think DocuBridge software is the best case scenario (in terms of budget). It can all get more complicated with any changes in value of the bullet points mentioned above.

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

That's interesting I did not know that publishing tools support drug or meddevs only within the package. AS I remember DocuBridge does not discriminate in this case.

P.S.: I do not work for Lorenz and not affiliated with them haha

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
------------------------------

Original Message:
Sent: 29-Oct-2019 11:16
From: Sorin Alb
Subject: eCTD Software Recommendations

I would add to Arthur's list:
- filing only one category (drugs) or more (drugs and medical devices)

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada

Original Message:
Sent: 29-Oct-2019 10:32
From: Artur Shchukin
Subject: eCTD Software Recommendations

Hello Brittany and Tina,

I am in the same situation as you guys. I have done my research and I agree with Sorin before searching for a publishing platform (web or software based) it is better that you answer yourself such questions as:
- what is the budget
- how many people from your organization will utilize that publishing tool
- how many submissions are intended to be published during the year
- what are the regions you are submitting to etc.

I have reached out to many companies (CuneSoft, master Control Lorenz etc... and for small companies with one publisher I think DocuBridge software is the best case scenario (in terms of budget). It can all get more complicated with any changes in value of the bullet points mentioned above.

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

In my experience, DocuBridge does discriminate between drugs or meddevs if you buy the "skinny package".
It's all about how much you pay and the kind of licence you buy.

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
------------------------------

Original Message:
Sent: 29-Oct-2019 11:30
From: Artur Shchukin
Subject: eCTD Software Recommendations

That's interesting I did not know that publishing tools support drug or meddevs only within the package. AS I remember DocuBridge does not discriminate in this case.

P.S.: I do not work for Lorenz and not affiliated with them haha

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States

Original Message:
Sent: 29-Oct-2019 11:16
From: Sorin Alb
Subject: eCTD Software Recommendations

I would add to Arthur's list:
- filing only one category (drugs) or more (drugs and medical devices)

------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada

Original Message:
Sent: 29-Oct-2019 10:32
From: Artur Shchukin
Subject: eCTD Software Recommendations

Hello Brittany and Tina,

I am in the same situation as you guys. I have done my research and I agree with Sorin before searching for a publishing platform (web or software based) it is better that you answer yourself such questions as:
- what is the budget
- how many people from your organization will utilize that publishing tool
- how many submissions are intended to be published during the year
- what are the regions you are submitting to etc.

I have reached out to many companies (CuneSoft, master Control Lorenz etc... and for small companies with one publisher I think DocuBridge software is the best case scenario (in terms of budget). It can all get more complicated with any changes in value of the bullet points mentioned above.

------------------------------
Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------

Hi,

You can also take a look at "eCTD office" as publishing software. You will buy one license annually for unlimited publishing every year.

------------------------------
Limin Wang
Bedford MA
United States
------------------------------

Original Message:
Sent: 23-Oct-2019 10:27
From: Brittany Cloud
Subject: eCTD Software Recommendations

I am in the process of starting eCTD compliant submissions. Does anyone have a recommendation as to which software is best to use? Thanks.

------------------------------
Brittany Cloud
Quality Assurance Manager
Lancaster PA
United States
------------------------------