Regulatory Open Forum

 View Only

  • 1.  Pediatric Development Vendor

    Posted 09-Nov-2015 16:34

    Hello All,

    My company is looking for a vendor to help us create our pediatric development strategy including the actual iPSP and PIP documents. Does anyone have a recommendation for someone they have used in the past?

    Thanks!

    ------------------------------
    Samantha Magazu
    Biota Pharmaceuticals, Inc.
    Alpharetta GA
    United States
    ------------------------------


  • 2.  RE: Pediatric Development Vendor

    Posted 10-Nov-2015 11:56

    Hi Samantha,

    I can recommend Cote Orphan as a vendor.  Tim Cote, Ex- Director of the Orphan Drug Division at FDA is the founder of Cote Orphan and in addition to generating submissions for orphan drug designation, can support pediatric plans, waivers, deferrals etc. 

    They have a web-site.

    Dar

    ------------------------------
    Darlene Rosario MBA, RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States

    Original Message


  • 3.  RE: Pediatric Development Vendor

    Posted 11-Nov-2015 08:52

    Hi Samantha,

    I sent you a message through the RAPS site with a recommendation.  Please reach out if I can be of any help.  Thank you.

    ------------------------------
    Andrew Verderame RAC
    President
    Pharmalex US, LLC
    Guilford CT
    United States

    Original Message