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Looking for recommendations for eCTD publishing vendors

  • 1.  Looking for recommendations for eCTD publishing vendors

    Posted 04-May-2018 16:29
    Hello, 

    Looking for recommendations for eCTD publishing vendors for our upcoming multiple IND submissions. 

    Thanks,
    RAPS Member

    ------------------------------
    Jyoti Chauhan, MS, RAC (US)
    Senior Regulatory Affairs Specialist
    ------------------------------


  • 2.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 06-May-2018 15:14
    Hi Jyoti

    My husband is head of the Regulatory Operations dept at TPIReg which is a consulting company with an eCTD publishing dept. I'm sure they will be able to support your multiple IND submissions. They can submit to FDA and Health Canada. Take a look at their website: www.tpireg.com - there is a Regulatory operations page. Or I can put you in contact with him by email if that's easier. 

    Thanks
    Sue

    ------------------------------
    Susan Evans MBA, RAC
    Head, Regulatory Affairs
    Victoria BC
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 06-May-2018 18:36
    Thanks Susan. I will take a look at the website and get in touch with him. 

    Thanks,
    Jyoti

    ------------------------------
    Jyoti Chauhan, MS, RAC (US)
    Senior Regulatory Affairs Specialist
    ------------------------------

    Original Message


  • 4.  RE: Looking for recommendations for eCTD publishing vendors

    This message was posted by a user wishing to remain anonymous
    Posted 09-May-2018 10:51
    This message was posted by a user wishing to remain anonymous

    I have used the software Lorenz Docubridge and the software from and services provided by EXTEDO and been happy.
    Original Message


  • 5.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 06-May-2018 22:13

    Hi Joyti,

    I learn from my colleagues that docuBridge is what ICON used so we are going to purchase their product.
    LORENZ Life Sciences: eSolutions | LORENZ docuBridge: Multi-User eSubmission Management & Production System

    Hope this information helps.



    ------------------------------
    Chiung-Hui Hung
    Senior Manager, Regulatory Affairs
    Zhubei City
    Taiwan
    ------------------------------

    Original Message


  • 6.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 06:29
    Dear Jyoti,

    We also provide eCTD publishing services. You can find more information here:  https://hartmannwillner.com/electronic-publishing-submissions/

    Thank you.

    Sincerely yours, Suzanne

    ------------------------------
    Suzanne M. Sensabaugh, MS, MBA
    President and Principal Consultant
    HartmannWillner LLC
    100 M Street SE
    Suite 600
    Washington, DC 20003
    Phone: 202-749-8616

    www.hw-fda.com
    ------------------------------

    Original Message


  • 7.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 07:17
    There are Publishing Services, where a company can generate the submission for you, and there are software tools so that you can build the submissions yourself.  Some companies both have software tools and engage publishing services, especially to assist with larger submissions.

    Of the software tools, there are desktop tools (for small organizations), Cloud tools and still some multi-user tools that you have to setup in your own environment.  Most eCTD software publishing tools can be setup in the cloud, and a number can also be setup using a third-party hosting service.
    You can 'purchase' the software (you own it but must also maintain it), which is usually the most expensive up-front solution (except for desktop tools).  Cloud and third-party hosting tools are generally subscription licenses, for a period of time.

    If you are moving from paper and do not have experience with eCTD software, it might be worth considering a consultant to help with your decision, which direction to go in, and training on the changes moving from paper to eCTD.

    I recommend the eSubmissions University for more information (started by a long term RAPS member and ex-President). 
    http://esubmissionsuniversity.com/

    While I do work for an eCTD software vendor, I hope these items are reasonably vendor neutral.

    Take care,
    Don

    ------------------------------
    Donald Palmer RAC
    Director, Product Strategy and Regulatory Informatics
    Langhorne PA
    United States
    ------------------------------

    Original Message


  • 8.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 07:42
    You may want to try PAREXEL International (www.PAREXEL.com) which offers complete Regulatory Affairs, publishing, and application submission services with offices in North America, Europe, and Asia including India.  PAREXEL routinely deals with international regulatory authorities with many ex-regulators on staff who also offer GMP/Quality System compliance services.  (I just retired from PAREXEL after 23 years.)


    Peter D. Smith

    Smith GMP Consulting, LLC

    35 Thayer Ave.

    Narragansett, Rhode Island 02882  USA



    ------------------------------
    Peter Smith
    Prin Consultant
    Narragansett RI
    United States
    ------------------------------

    Original Message


  • 9.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 08:36
    I believe DocuBridge is the best bet for today. Even FDA is moving towards using that or already using that.

    ------------------------------
    Artur Shchukin
    New York NY
    United States
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    Original Message


  • 10.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 09:21

    Good Morning Jyoti, 

    Network Partners provides worldwide electronic submission publishing services (eCTD) (New to eCTD? Network Partners is ready to help! - Network Partners. 

    I would be happy to set up a call to discuss your needs.  I can be reached at ratinder.dhami@networkpartners.com. 

    All of our pharmaceutical regulatory services are outlined here: Pharmaceutical Regulatory Affairs | Network Partners.   

    Kind Regards, 
    Ratinder



    ------------------------------
    Ratinder Dhami RAC
    Senior Scientific Advisor, Regulatory Affairs
    Network Partners
    ------------------------------

    Original Message


  • 11.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 07-May-2018 18:12
    b​Jyoti,
    Mandava Associates, LLC was founded in 1986 by former senior managers from FDA and EPA. It is a full service company. For details, please visit: Mandava Associates
    Mandava remove preview
    Mandava Associates
    Clinical Research Organization, Scientific Regulatory Consultants - new drugs, medical devices, antimicrobial products; agriculture, household, industrial and institutional pesticides; specialty chemicals.
    View this on Mandava >



    ------------------------------
    N. Bhushan Mandava PhD
    President
    Washington DC
    United States
    ------------------------------

    Original Message


  • 12.  RE: Looking for recommendations for eCTD publishing vendors

    Posted 10-May-2018 09:52
    Hi Jyoti,
    Cardinal Health has a Regulatory Sciences consulting group that has eCTD Publishing capabilities.  Take a look here: Regulatory Submission Operations
    Cardinalhealth remove preview
    Regulatory Submission Operations
    Cardinal Health offers customized solutions for eCTD publishing and eCTD submission. Learn more about our eCTD guidance services.
    View this on Cardinalhealth >



    ------------------------------
    Kaitlyn Riffel
    Kansas City MO
    United States
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    Original Message


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