Quality Management
Di Renzo Regulatory Affairs has a special unit dedicated to quality services, made up of qualified professionals, with a wide experience in this field. Advice on quality is addressed to companies and bodies wishing to comply with the provisions of UNI EN ISO 9001, UNI CEI EN ISO 13485, UNI EN ISO 22716, GXP (GMP, GDP, GCP, GVP), as well as the Farmindustria Guideline for Scientific Information.
The main services offered are:
- Assistance to prepare and update a quality Management System according to ISO 9001
- Assistance to prepare and update a quality Management System according to ISO 13485
- Support for the drafting of the company organisation chart
- Preparation of the Job Description
- Preparation of the Quality Manual or evaluation of the one already used by the client
- Drafting of Standard Operating Procedures (SOPs) and optimisation of management procedures for all sectors of the regulatory activities
- Review of technical agreements
- Audits at companies and suppliers
- Taking on the role of Quality Assurance
- Contacts with Certification Bodies
- Preparation of the records system to ensure the compliance with the procedures and the manual
