Regulatory Open Forum

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  • 1.  Compounding Pharmacy

    Posted 23-Apr-2022 15:14
    I'm looking for recommendations for RA/QA consultants who are specifically familiar with and well-versed in the FDA regulations and requirements for compounding pharmacies and who may be able to assist in an evaluation of a compounding pharmacy group's current state of compliance.  Any suggestions or thoughts would be appreciated.

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    Christopher Smith, CQE, RAC
    Coastal Pharmaceutical Consultants, Inc.
    7950 Old River Road
    Burgaw, NC 28425, USA
    910.789.1232 (mobile)
    chrissmith@coastalpharmaconsultants.com
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  • 2.  RE: Compounding Pharmacy

    Posted 24-Apr-2022 10:46
    Kristopher Le, Pharm.D., at Amicus GMP Consulting. Compounding pharmacies are his focus area.

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    Paris Hamilton, Ph.D., RAC (Drugs, U.S.)
    CMC Consultant
    Voisin Consulting Life Sciences (VCLS)
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