In the frame of a strong enhancement of our activities for audits, Di Renzo Regulatory Affairs hired new qualified resources in order to widen our consulting offer.
Inspections are carried out in line with the following provisions:
- GMP (in the manufacturing of both finished products and active substances)
- ISO 13485 (in each step of the manufacturing process of a medical device, from its development to its distribution, up to the post-marketing surveillance)
- GDP (offering support for both the start-up phase and the obtaining of the authorisation)
- ISO 22716
- ISO 9001
The services involved are the following:
- Audits at manufacturing sites, warehouses for medicines, medical devices, food supplements, cosmetics, biocides, raw materials (APIs), PMCs (presidi medico chirurgici, medical surgical aids)
- Audits for pharmacovigilance, vigilance and surveillance activities for medical devices and cosmetics
- Audits at national and foreign suppliers and business consultants
- Audits at the company’s national and international branches
- Audits at national and international companies carrying out batch release activities.
- Audits for the activities of the pharmaceutical scientific service.
- Cooperation in the preparation and revision of SOPs and quality documentation.
- Cooperation in the management of the company quality service
- Business refresher training
Following this new hiring, Di Renzo Regulatory Affairs can count on a unit of several technicians qualified for the performance of the activities listed above.