Zimu counsels US and international biotech, pharmaceutical, medical device and other life sciences companies on a range of Food and Drug Administration (FDA) regulatory, compliance and enforcement matters. He advises on issues related to pre-clinical development, clinical trials, marketing authorization, manufacturing, market access, promotion and sales, product safety, imports and exports, and cybersecurity. He also frequently advises on regulatory issues involving novel products, including software medical devices, general wellness products and embryo preimplantation genetic testing.
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