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FDA Regulatory Representation for Medical Device Company Represented a long standing biologic/device client who manufactures and distributes platelet-rich plasma (PRP) producing devices. Advised the client on a variety...
FDA Regulatory Advice Prepared ANDA and 510(k) submissions for Spectra Medical Devices, as well as regulatory and business advice, which allowed the client to meet their contractual obligations.
FDA Regulatory Advice in Pharmaceuticals and Medical Devices Assisted Exalenz Biosciences Ltd in developing and obtaining FDA clearance of drug/diagnostic combination product for diagnosis of certain diseases.
FDA Regulatory Advice Assisted with obtaining FDA approval of pharmaceuticals and medical devices for Medefil, Inc.