Compliance is the best medicine.

It takes great diligence and dedication to ensure compliance with the widely varying laws and regulations concerning global distribution of named patient medicines. It is absolutely critical. Business depends on it. Lives depend on it.

PTSI Account Application and Qualification process ensures that the importing facilities meet strict regulatory, legal, and ethical standards. PTSI Controlled Export ensures that products are properly tracked and traced throughout the entire supply chain.

PTSI works directly with the manufacturer to obtain documentation required by local authorities of the importing country, for example:

  • Product Prescribing Information
  • Material Safety Data Sheets (MSDS)
  • Product Stability Data
  • Certificates of Analysis (COA) or Certificates of Compliance (COC)
  • Technical Inquiry Data
  • Product Quality Data
  • Country-specific Documentation, such as UK-required TSE Statement
    (Transmissible Spongiform Encephalopathy)