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Maham Ansari

Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.

• Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

  Translational Research - Regulatory - Assays - Gene Therapies

  Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

  Jan 07, ‘25 | 12 min read

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  • Deborah P.

    Maham A.

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• Read: Regulatory Risk Management Using Third-party Distributors

  Clinical Trials - Manufacturing - Regulatory

  Regulatory Risk Management Using Third-party Distributors

  Mar 02, ‘22 | 3 min read

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    Maham Ansari

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