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
