FDA Approval Processes
Through a multidisciplinary team of industry, regulatory, and scientific specialists, Gershon Capital helps organizations to prevent and resolve compliance problems and to develop efficient and effective strategies for the submission and approval of drugs, biologics, and devices. The firm deploys only highly experienced consultants who consistently deliver top-quality results for a diverse base of global clients—including pharmaceutical biologic, biotechnology, medical device, and dietary supplement companies and the law firms that serve them.
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FDA Regulatory Affairs and Compliance
Through a multidisciplinary team of industry, regulatory, and scientific specialists, Gershon Capital helps organizations to prevent and resolve compliance problems and to develop efficient and effective strategies for the submission and approval of drugs, biologics, and devices. The company deploys experienced consultants with in-depth industry and agency experience who consistently deliver top-quality results for a diverse base of global clients—including pharmaceutical biologic, biotechnology, medical device, and dietary supplement companies and the law firms that serve them.
Areas of expertise include:
• Changing Requirements and timing of regulatory filing, reviews and approvals.
• Post Launch Requirements.
• Good Clinical Practice & BE/BA Bioanalytical Testing FDA Field Reviews.
• New/Tighter policies and requirements for safety and clinical trials for device products.
• USA/EU/Global compliance environment.
• Selection of an Agent and their Responsibilities.