Quality Assurance and Audits
Pharegistrum provides quality assurance consultancy for pharmaceutical and healthcare businesses. We support the implementation and review of management systems, preparation of documentation and licensing procedures.
Quality management systems
Support may involve establishing a quality management system or reviewing an existing one. The scope is adapted to the company’s activities, products and identified needs.
- Implementation, review and maintenance of quality management systems.
- Preparation of quality manuals and standard operating procedures (SOPs).
- Implementation of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Risk management plans within the scope of ISO 14971.
Audits, licensing and technical support
- Audits within the scope of GMP, GDP, ISO 13485 and ISO 9001.
- Manufacturing and distribution licensing applications and follow-up.
- System maintenance with the assignment of technical responsibilities (DT, RT and TR).
- Support with transfers between logistics operators.
These services cover activities involving medicines, medical devices, food supplements, cosmetics, veterinary products, biocides and detergents.
What support does your company need?
For an audit, procedure review or system implementation proposal, describe your activities, relevant sites and available documentation. We can assess whether the request calls for a specific intervention or a broader quality project.
