Assist a Start-up Company with Marketing and Selling its Pharmacy Compounding System
We provide corporate and regulatory advice to a start-up company that markets and sells a pharmacy compounding machine and its associated software topharmacies to aid them with the compounding process
Assist Covered Entities and Contract Pharmacies with 340B Drug Discount Program Compliance
We assist various health care providers with 340 Drug Program enrollment, registration, compliance, billing and reimbursement, contract negotiation, and disclosure and settlement negotiation related to non-compliance with program requirements.
Provide Ongoing Legal and Compliance Counsel to a Specialty Pharmacy Chain
We serve as outside general counsel for a nationwide retail and specialty pharmacy company headquartered in Pennsylvania. We advise the company on legal and regulatory strategies and work with its leadership, sales and clinical teams to address complex and rapidly-evolving health care regulatory issues.
Provide Ongoing Strategic Counsel to a Start-Up Prescription Delivery Company
We provide general corporate and health care regulatory advice and strategiccounselto a start-up company that partners with health plans and pharmacies to coordinate prescription delivery and other adherence-boosting services, with the goal of improving health care outcomes and reducing health care costs.
Represent Multiple Compounding Pharmacies
We represent a number of compounding pharmacies, providing advice related to FDA and State of Ohio Board of Pharmacy regulatory requirements for drug compounding and assistance with regulatory inspections.
Represent Pharmacists and Other Providers Before the State of Ohio Board of Pharmacy
We represent pharmacists, pharmacies, and other providers before the State of Ohio Board of Pharmacy to assist them with obtaining licensure, navigating the disciplinary hearing process, negotiating settlements.