Regulatory Open Forum

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  • 1.  TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 01-Sep-2023 05:57
    Hi All,
     
    We are looking for consultants experienced in TGA(Therapeutic Goods Administration) Australian regulatory filing.
    Please let me know if anyone has this experience.
     
    Thanks in Advance.
     
    Best Regards,
    Sandeep


    ------------------------------
    Sandeep K S
    bengaluru
    India
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  • 2.  RE: TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 02-Sep-2023 20:14

    Is this a gene therapy product.



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    Sharon Spratt
    Chief, Regulatory Affairs
    Edmond OK
    United States
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  • 3.  RE: TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 03-Sep-2023 02:57

    Hi Sandeep

    Greetings!! Metina can support in TGA filing, pl do share request at hasumati@metinapharmconsulting.com OR shobhna@metinapharmconsulting.com.

    Thanks, Dr Hasumati 

    +919820113613



    ------------------------------
    Hasumati Rahalkar RAC
    Navi Mumbai
    India
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  • 4.  RE: TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 04-Sep-2023 01:49

    No, this is not gene therapy product.



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    Sandeep K S
    bengaluru
    India
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  • 5.  RE: TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 03-Sep-2023 19:28

    Dear Sandeep,

    We can help with your TGA regulatory submissions. Pharmalex is a global pharma and devices regulatory consutling frim and is the largest and most experienced regulatory consulting firm in Australia.

    We have a strong team of consultants who can assist with all your pre-market and post-market needs.

    Do reach out and we can arrange someone to contact you to discuss how we may be able to support you.

    Regards



    ------------------------------
    Yervant Chijian
    Director/Team Lead Medical Devices/IVDs
    Pharmalex Pty Ltd
    St Leonards NSW
    Australia
    ------------------------------



  • 6.  RE: TGA(Therapeutic Goods Administration) Australian regulatory filing

    Posted 04-Sep-2023 01:53
    Hi Yervant,

    Thank you for the response. We will get back to you soon.

    Best Regards,

    Sandeep K S
    Consultant

    IND: +91 9945026226

    Maruthi Quality Management Services

    India , Netherlands

    www.maruthiquality.com