Are You and Your Suppliers Ready for Drug Serialization?

Are You and Your Suppliers Ready for Drug Serialization?   QPharma understands the need to manage compliance to the Drug Supply Chain Security Act through lean project management. Have you assessed readiness – both yours and your CMOs? Have you aligned these standards across your CMOs and your entire supply chain? Have You Considered All [...]

Privacy Policy

U.S. – E.U. SAFE HARBOR PRIVACY POLICY We self-certify compliance with: QPharma, Inc. (“QPharma”) is firmly dedicated assisting pharmaceutical stakeholders, whether pharmaceutical and medical device manufacturers, wholesale distributors, labelers, as well as sales support companies, to understand the regulatory compliance environment that may directly affect their business, and QPharma provides services and resources to such [...]

The Opioid Dilemma: Guiding Physicians to Compliance

by Matt Crusan — Director, DEA Compliance and Services The country is facing an epidemic as the rise of pain medication abuse and addiction spreads through big cities and into small towns, raising understandable concerns from the Drug Enforcement Administration (DEA), physicians, attorneys, and the patients themselves. Pain medicines — often opioids — are prescribed to patients [...]

Investing in Compliance

Ed Sleeper — Managing Director, Commercial Strategies and Solutions, QPharma Jennifer Schmidt, MBA — Product Manager, LMS and Training Solutions, QPharma You’ve probably taken an online compliance training course at one time in your career — perhaps even recently.  Did you click through it in record time and then try your best to pass the assessment?  Don’t [...]

The Sunshine Act Has Been Finalized … What Has Changed?

In February, the Center for Medicare and Medicaid Services (CMS) released the final rule of the Physician Payment Sunshine Act, which requires applicable manufacturers of drugs, devices, biologics or medical supplies to disclose financial relationships, payments, and other transfers of value to physicians and teaching hospitals.  With the June 1 Healthcare Practitioners (HCP) Expenses and Transfers of [...]

QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement. “In general, industry participants at [...]

Establishing Robust SOM Programs

by Matt Crusan — Director, DEA Compliance and Services   In accordance with Drug Enforcement Administration (DEA) rules, drug manufacturers and distributors are mandated to design and implement a system that identifies suspicious ordering activity of controlled substances; however, there is no clear guidance provided for how to establish a perfect Suspicious Order Monitoring (SOM) program.  Industry [...]