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Expertise: As a strategic pharmacy lawyer, I specialize in navigating complex regulatory landscapes governed by the FDA, DEA, and OIG. With over two decade of experience, I advise and represent compounding pharmacies, including 503A traditional compounders and 503B outsourcing facilities, ensuring compliance with cGMP standards, adverse event reporting, and inspection readiness. My expertise shines in high-stakes areas like intrathecal therapies for pain management, IVIG infusions for immunological disorders, and specialty pharmaceuticals involving biologics and controlled substances. I've successfully defended clients in audits, enforcement actions, and litigation, minimizing risks while optimizing operational strategies for innovative patient care. I also have exceptional experience with payer contracting.

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