The ability to deliver drug products efficiently and safely is a hallmark of the healthcare industry.  This includes protection of the nation’s drug supply in the face of attempts to introduce suspicious, counterfeit and substandard products.  Companies must navigate through myriad Federal and State licensing, security, labeling (e.g., serialization) and documentation (e.g., track and trace) requirements.  HPM regularly advises clients on the appropriate licensing, labeling and documentation required to maintain authority to sell their drug products that are compliant with Federal (e.g., DSCSA) and State laws and regulations.  HPM works with manufacturers, distributors and pharmacies, and has assisted clients in developing strategies for effective security in handling drug products throughout the distribution chain.

Our services

  • Compliance and Security Audits
  • Licensing and Approvals
  • Drug Labeling and Serialization
  • Government Investigations
  • Enforcement and Litigation