Complete Quality System Development & Implementation
Using your software and our consulting, we will assist you in meeting the FDA’s Good Manufacturing Practices (cGMPs) – 21 CFR Parts 210, 211, 606, and 820, from complete quality system set-up to providing guidance in addressing what needs to be improved.
Auditing Services – Compliance Audits (Both FDA & DEA), Supplier Audits
Our auditing services will allow you to quickly identify where your or your suppliers’ gaps exist, matching requirement to gap.
Validation, Commissioning & Qualification Services
In addition to providing system validation and ensuring compliance with 21 CFR Part 11, we also provide complete process validation as well as commissioning and qualification services for your equipment. Please contact us with your specific needs.
General Compliance Consulting
We haves experience in dealing with the FDA, DEA and the various state boards throughout the country. We are happy to assist you with all of your regulatory concerns.