Regulatory Open Forum

 View Only
  • 1.  eCTD submissions

    This message was posted by a user wishing to remain anonymous
    Posted 25-Apr-2017 12:52
    This message was posted by a user wishing to remain anonymous

    Hello All, 

    I am working for a small company looking to get started in e-submissions.  I would like to find an expert in e-submissions who is willing to chat more on this subject.  I have questions such as software recommendations, timelines and billing.  
    Any assistance would be appreciated! 

    Thank you in advance! 



  • 2.  RE: eCTD submissions

    Posted 26-Apr-2017 08:23
    Greetings,

    It is in exciting time to bring online electronic services to a company. I have been in industry for 25 years and working with electronic submissions for the last 8 years. My experience includes using a vendor for services, selecting a software to utilize in-house and starting up a company to be a service provider for electronic submissions. Please feel free to reach out and I will try and help with as many questions as I can.

    ------------------------------
    Lisa Johnson
    Managing Partner
    Avalis Publishing
    Boulder, CO
    Ph: 303-579-5212
    Email: lisa@avalispublishing.com
    ------------------------------



  • 3.  RE: eCTD submissions

    Posted 27-Apr-2017 12:13
    Hello, Lisa!
    <includetail> </includetail>

    Are your help is free or you need to charge us some?
    Thanks.

    Roy Feng, PhD, RAC
    HisunPharma





  • 4.  RE: eCTD submissions

    Posted 26-Apr-2017 12:43

    Hello!

    I understand that you are looking for some guidance regarding eSubmissions.  My firm currently provides electronic submission services to US customers as well as international customers.  Please feel free to reach out to me with your questions.

    Mary Waters
    Senior Consultant for Hartmann Willner
    email: mlwaters@hartmannwillner.com
     

    www.HartmannWillner.com

     



    ------------------------------
    Mary Waters
    Hartmann Willner
    Washington DC
    United States
    mlwaters@hartmannwillner.com
    ------------------------------



  • 5.  RE: eCTD submissions

    Posted 27-Apr-2017 05:56
    Hello

    I understand you are looking for some assistance with regard to e-Submissions, I will be able to help you on all your queries as freelancer if you do not wish to engage a full time consultant and if you are willing to work on individual basis.

    I have broad experience of working on e-Submission for all markets across the globe

    I can also refer you some best consultancies which could do the work for you at the best price.

    Please feel free to contact me

    Best Regards

    ------------------------------
    Gouspasha Mohammed
    mohd.gous@gmail.com
    Hyderabad
    India
    ------------------------------



  • 6.  RE: eCTD submissions

    Posted 27-Apr-2017 07:37

    Electronic submissions are certainly here to stay.  Understanding the "ins and outs" will save a lot of time and effort.  Even if you use a service, there are many things you need to know.  Have you looked at e-submissions University?  It is a non-profit focused on education for this specific topic.  The cost of admission is well worth it.  The website is http://esubmissionsuniversity.com/.  Good luck!

    Cheers,
    Melissa



    ------------------------------
    Melissa Walker RAC
    President & CTO
    Graematter, Inc.
    St Louis MO
    United States
    ------------------------------



  • 7.  RE: eCTD submissions

    Posted 27-Apr-2017 09:34
    Hi there!

    I am one of the instructors at eSubmissions University.

    In addition, I have been involved in electronic submissions since 1994 when I focused on life sciences document management and electronic submission publishing.

    I advise all sizes of companies in the transition to electronic submissions.  In addition, I have a fully-validated cloud-based environment for eCTD and eCopy publishing for providing electronic submission publishing services. Plus I have MS Word templates for authoring the content of eCTD and eCopy submissions.

    Feel free to contact me with your questions.

    I can be reached at:

    Mobile 619-787-1514
    Email aazevedo@e-submissionssolutions.com

    ------------------------------
    Antoinette Azevedo
    President & CEO
    San Diego CA
    United States
    ------------------------------



  • 8.  RE: eCTD submissions

    Posted 27-Apr-2017 10:24

    I'm not an expert in e-submissions, but like you we are a small company that converted to eCTD (from paper based non-CTD)  about 8 months ago.  I can just discuss our experience with you if you're interested.



    ------------------------------
    Tooba
    United States
    ------------------------------