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Medicines

Quality and controlled medicines

We prepare quality documentation (Manual and SOPs) and the templates required for dispensing controlled medicines (PRT 344/1998, RDC 735/2022), with support for bookkeeping validation.

What we deliver

  • Initial Quality Manual and basic SOPs according to the activity
  • Document templates and a guide for controlled medicines
  • Support for bookkeeping validation with the local health authority
  • Final review and adjustment after the gap analysis

Who it's for

Companies that need to structure a quality system or operate with controlled medicines.

Documents we usually request

  • Description of the company's processes and activities
  • Licenses and technical manager
  • Information on the dispensed medicines

Not included

  • Customization per technical manager and per company
  • Implementation and training
  • Full quality-system implementation