|
Your Best Resource |
|
When it comes to meeting FDA regulatory and compliance requirements experience counts, and we deliver |
|
Quality Systems |
|
One of the biggest mistakes in life science industry is the lack of attention to the importance of a good quality management system and increasing numbers of warning letters and FDA 483s are indications of this fact.
With special focus on start-up companies, QICI helps life science companies to build and improve their quality systems in order to be fully in compliance with FDA regulations. We help our clients to receive required state licenses for their operations sooner and FDA approval for their products faster. We provide following services:
● Development of quality strategy and set up quality system for start-ups thru: ◦ Drafting new procedures ◦ Review of records for compliance ◦ Employee trainings; and ◦ Preparation of master production record ◦ Preparation of Raw material specifications ◦ Identification of required tests for raw materials, in-process, and final products ◦ Preparation of Stability protocols and writing reports for completed studies ◦ Preparation of Labeling and packages records and design
● Due Diligence and gap analysis evaluation of existing Quality Systems to identify following problems and issues
◦ Deviations and discrepancies identification and root cause analysis ◦ OOS (Out of Specification) and OOL (Out of Limits) identification and investigation of ◦ Non-conforming materials identifications ◦ Preparation for FDA PAI inspection ● Risk Assessments and Risk Management
We help clients to identify risks associated with their product design and system as it is required by QbD (Quality by Design).
● Site master file preparation (EU requirements)
● Quality manual preparation (ISO 9001 and 13485) |
|
● Quality Systems setup (GMP, GLP, QSR, and ISO 13485) ● Gap analysis ● Due diligence audits
|
|
Quest International Consulting 26180 Enteprise Way Suite 300 Lake Forest, CA 92630 USA Phone: 949-297-4445 Fax: 949-215-3434
|
|
Full QS Services: |
