Find your exposure before the FDA finds it.

James Strafuss is the President of MUSTEC LLC and founder of MedPharma USA, a licensed healthcare distribution platform serving physician practices, specialty clinics, and regulated healthcare manufacturers.

With more than two decades in federally regulated business environments, James has built operational systems for organizations under oversight from the SEC, the DOJ, and executive-level federal institutions.

He holds active Designated Representative (DR) status in multiple states carrying personal accountability for wholesale drug distribution, recordkeeping integrity, and Board of Pharmacy compliance.

His DSCSA expertise spans trading partner requirements, serialization, ATP validation, suspect product procedures, and transaction data reconciliation across manufacturers, distributors, and dispensers.

Unlike theoretical compliance advisors, James operates inside the regulated structure itself implementing controls across licensure, vendor credentialing, lot tracking, and inspection-readiness within active distribution environments.

Through Claritas Axis Group, he translates complex statutory requirements into executable operational systems helping practices understand where risk lives before an inspector finds it.

His work reflects direct accountability under the law not commentary on it.