Qualified Person / Quality Assurance

Dor Pharmaceutical Services provides a broad range of proven, certified Qualified Person (QP) and Quality Assurance (QA) services to help companies meet GMP guidelines and Israeli Ministry of Health (MOH) regulations. These oversight services cover new product launches and ongoing product maintenance, as well as investigational products (clinical trial certification). Dor’s services verify continued product safety, effectiveness and consumer satisfaction — from product manufacturing to the pharmacy shelf and beyond by:

  • Establishing and maintaining quality systems to meet local regulations (importer license)
  • Providing qualified person (QP) certification, outsourcing and insourcing, including batch release services
  • Managing quality assurance
  • Creating quality agreements / technical agreements with suppliers
  • Conducting internal and external quality and supplier audits, including overseas manufacturer audits; Read more…
  • Developing and maintaining standard operating procedures (SOP)
  • Overseeing distribution systems
  • Conducting pharmacovigilance and device vigilance activities; Read more…
  • Providing medical information to caregivers and patients; Read more…
  • Managing complaints and contacts
  • Preparing for agency or internal corporate inspections (mock audits); Read more…
  • Training teams and writing documentation
  • Performing clinical trial quality assurance