* Focused on providing legal, regulatory, and clinical assistance to pharmaceutical and biopharmaceutical products, especially starting at the point of post-IND assistance through commercialization of the product.
* Helping US based and international companies manage the myriad of regulations from FDA, HHS, OIG, US Attorney's Office, DOJ, etc. as are applicable to the discovery, manufacture, and sale of pharmaceutical and biopharmaceutical products.
* Legal, clinical, teaching, and regulatory backgrounds allow me to assist pharmaceutical companies and their service providers ranging from 1 person consultants to multi-billion dollar, multi-national pharmaceutical companies in US-related legal, regulatory, and compliance activities.

Specialties: Regulatory and Legal Compliance for Life Sciences Companies including Compliance with the False Claims Act, Anti-Kickback Laws, HIPAA, Starke Laws, FCPA, etc., Synergizing and Synchronizing IP and Regulatory Goals, Promotional Review and Compliance, Clinical Trial Legal and Regulatory Assistance, US-International Cross Border Transactions focusing especially in US-Indian Pharmaceutical Trade.