MCRA is the leading therapy focused CRO and advisory firm and the pioneer in integrating multiple core service offerings to support the biotech and medical device industries.
Our Experience in Cell & Gene Therapy
MCRA’s Cell and Gene Therapy Team provides expert regulatory strategy and clinical development consulting support relating to advanced therapies through development to commercialization. Core product focus areas include:
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Cell Therapies
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Gene Therapies
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Exosomes
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Delivery Devices
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Combination Products
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Companion Diagnostics
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Advanced Manufacturing
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Breakthrough and RMAT Designations
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Rare Diseases
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Biologics Quality & Compliance
Contact a Cell & Gene Therapy Expert
Meet Our Cell & Gene Therapy Team
Led by predominant leaders in the field with over two decades of FDA regulatory experience, MCRA's Cell & Gene Therapy team bring their experience and deep insight of the innerworkings of the Center for Biologics Evaluation and Research (CBER) policy and regulatory review to MCRA’s clients to effectively navigate this complex regulatory framework. Meet our expert team below.
