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  • 1.  SPL labeling service provider

    Posted 14-Oct-2015 18:42

    Hi. All,

     

    Any one can recommend one or some vendors for me? We have done the insert label word and pdf works but need to prepare the SPL labeling for our ANDA submission.

    Thanks a lot!

     

    Jingyang


    ------------------------------
    Jingyang Zhu
    Downingtown PA
    United States
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  • 2.  RE: SPL labeling service provider

    Posted 15-Oct-2015 07:53

    Life Sciences Solutions - Reed Tech

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    This is the company we use for SPL creation etc.

    John
    ------------------------------
    John Lay
    Director, Regulatory and Quality
    Vistapharm Inc.
    Largo FL
    United States
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    Original Message


  • 3.  RE: SPL labeling service provider

    Posted 15-Oct-2015 10:02

    Thanks to everybody for your big help!

    ------------------------------
    Jingyang Zhu
    Downingtown PA
    United States
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    Original Message


  • 4.  RE: SPL labeling service provider

    Posted 15-Oct-2015 10:35


    I would recommend SPLPortal by Regulatory Compliance Software | Intagras

    We've used them for many years and their knowledge and level of service is outstanding.

    Best of luck!
    ------------------------------
    Anelis Aurand-Araos RAC, CSSBB
    Director, Regulatory and Quality Affairs
    Wellspring Pharmaceuticals
    Sarasota FL
    United States
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    Original Message


  • 5.  RE: SPL labeling service provider

    Posted 15-Oct-2015 08:40

    We have used Intagras in the past and been very happy with their service.




    Original Message


  • 6.  RE: SPL labeling service provider

    Posted 15-Oct-2015 09:12

    Hi Jingyang, 

    I work at Reed Tech and can help walk you through the SPL labeling and listing processes.  We have worked on many ANDA submissions and can absolutely assist you.  Please feel free to send me an email and we can schedule a phone call.  Here is my contact information:

    Andrew Ethridge

    7 Walnut Grove Drive, Horsham, PA 19044

    O: +1-215-734-6536 | C: +1-267-688-0986

    aethridge@reedtech.com | ReedTech.com

    ------------------------------

    Andrew Ethridge
    Horsham PA
    United States
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    Original Message


  • 7.  RE: SPL labeling service provider

    Posted 15-Oct-2015 09:52

    I use Intagras. They are fast and affordable

     

    http://www.intagras.com/

     

    Francisco J. Lozano, BSc, MBA, RAC

    Vice President of Quality and Regulatory Affairs

    Humco Holding Group, Inc.

     




    Original Message


  • 8.  RE: SPL labeling service provider

    Posted 15-Oct-2015 12:09

    If this is a one time thing, as in the case of an ANDA submission I would recommend outsourcing the job to one of the above mentioned vendors (Intagras) instead of buying the software. If this is an ongoing thing where you plan to submit a lot of SPL's (more than 100/year) then I would recommend going for he software. 

    ------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
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    Original Message