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    Four principals lead every engagement
    Kristopher Le, PharmD, CEO and Founder of Amicus

    Kristopher Le, PharmDCEO & Founder

    Don Carter, Principal, Validation at Amicus

    Don CarterPrincipal, Validation

    Jamie Duncan, CQA, Principal, Quality at Amicus

    Jamie Duncan, CQAPrincipal, Quality

    Becca Mitchell, PharmD, Principal, Quality and Regulatory at Amicus

    Becca Mitchell, PharmDPrincipal, Quality & Regulatory

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    Phone(803) 839-0202

    Office1122 Lady St, 3rd Floor
    Columbia, SC 29201

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Day: March 12, 2026

Novo Nordisk and Hims & Hers Partner to Expand Access to GLP-1 Treatments

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Novo Nordisk and Hims & Hers are partnering to widen access to branded GLP-1 treatments, shifting demand away from compounded products. What it means for compounders and clinical sponsors.

FDA Inspection Trends Highlight Ongoing Quality System Weaknesses

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Recent comments from an FDA investigator point to the same recurring Form 483 themes: quality unit oversight, procedures not followed, and investigations that do not close the loop.

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Why Amicus

  • 125+ years combined GMP experience
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  • Practical, sustainable quality solutions, not just gap reports

Contact Details

Tel : (803) 839-0202
Address : 1122 Lady St, 3rd Floor, Columbia, SC 29201, USA
Business Hours : 8.00 AM to 5.00 PM

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