Regulatory Open Forum

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  • 1.  Regulatory support

    Posted 13-Feb-2024 22:07

    Hi all,

    New to the RAPS community and had a request for regulatory support:

    1. My company is looking for support for drafting/reviewing clinical and pre-clinical modules for an upcoming FDA IND submission. Any suggestions on companies or consultants who provide this expertise?
    2. We are in the market for a portal to archive word and pdf versions of regulatory documents. Ideally this portal would also allow us to edit draft documents and send documents for review. Any suggestions for companies who provide this service?

    Any and all suggestions would be appreciated!



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    Samantha Brew
    Head of Program Management
    Skokie IL
    United States
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  • 2.  RE: Regulatory support

    Posted 13-Feb-2024 22:18
    1. Check with Voisin Consulting Life Sciences (voisinconsulting.com)
    2. It sounds like you're looking for a system like Veeva or something more like SharePoint. 


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    Paris Hamilton RAC, PhD
    Associate Director, CMC Global Regulatory Affairs
    Voisin Consulting Life Sciences (Massachusetts)
    Chesterfield VA
    United States
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    Original Message


  • 3.  RE: Regulatory support

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2024 09:18
    This message was posted by a user wishing to remain anonymous

    My recommendations are as follows:

    Any CRO who has previously authored several CTDs for IND should be ok, so the main thing to ask is the cost of doing it!

    Secondly, these authors for CTD modules would be reviewing you preclinical study reports to summarize or tabulate the main points in CTD modules so therefore medical writers/clinical writers or preclinical writers are what you are actually looking for to complete the CTD for IND. Dont'd forget the CMC writers depending on whether your is small molecule/biologics etc.

    To oversee these writers for IND submission, I'd strongly recommend a regulatory strategist who is familiar with the therapeutic area of focus/corresponding FDA therapeutic division to jump in and advise these writers or even rephrasing the initial write ups or narratives that are palatable to the FDA review division

    If you happen to select a CRO, make sure the above points are factored in to complete your IND. Lot of CROs will claim they are the regulatory experts but be aware most of them are not and mostly do cut and paste which may not be relevant to your specific therapeutic area of focus and your specific objectives! This is why an experienced regulatory strategist is very crucial in accomplishing your tasks.

    Good luck!


    Original Message


  • 4.  RE: Regulatory support

    Posted 14-Feb-2024 10:17

    Hi Samantha,  could you provide more details about the product?  Is this a small molecule or biologic?  Combination product?  My company may be able to help.  Feel free to contact me at the e-mail below.

    Thank you,



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    Janet DeLeon
    CEO
    DeLeon Pharmaceutical Consulting, LLC
    janet@deleonpharma.com
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    Original Message


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