Services
We Can Help
Our Team of 3rd party FDA Auditors have over 100 years of experience to assess and assist your company in obtaining FDA regulatory and compliance requirements
Auditing
- Design Specific Audit Schedules
- Conduct Internal Audit with GAP Analysis
- Conduct External Audits of Suppliers and Sub-Contractors
- Prepare Audit Reports with Recommended Corrective Actions
- Conduct Follow-up Audits
Documentation QSR/GMP/ISO Training
- Evaluate Existing Documentation System
- Create a Basic Documentation System
- Implement a Documentation System
- Write Documents (Quality Manual, SOPs, Work Instructions)
- Conduct Training to New/Revised Documents
- Evaluate Existing Training Programs
- Design and Conduct Tailored Training Programs
PMA NDA 510(K) Filings
- Write NDAs/ANDAs, PMAs, PLAs/BLAs, 510(k)s
- Evaluate Existing NDAs/ANDAs, PMAs, PLAs/BLAs, 510(k)s
- Design a Plan of Action to Address Identified Deficiencies
- Establish and Implement Timelines to Meet Filing Dates
How Can We Help You
Location
3104 East Camelback Road, Suite 571,
Phoenix, AZ, 85016
N.Williams@FDAConnection.com
