Pharma & Biotech
ECL2 assists companies struggling with how to find the balance in complying with regulations while still meeting operational requirements. Not finding that balance can be costly in both directions. If you aren’t complying, you are putting your organization and the patients using your products at risk. If you put in a quality system that not only meets the requirements, but places a significant burden on operations than it adds significant costs. We provide the expertise needed to help you make these decisions.
Complete Quality System Development & Implementation
Using Q-Pulse software and consulting, we will assist you in meeting the FDA’s Good Manufacturing Practices (cGMPs) - 21 CFR Parts 210 & 211 and 606 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 supplier’s gaps exist, matching requirement to gap. We also have expertise in complying with the German Health Ministry Regulations for Blood Products.
Validation, Commissioning & Qualification Services
ECL2 is the U.S. preferred provider for validation services for those seeking validation of their automated quality management system. Please click here for more on automated quality management systems. 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
ECL2 has 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.
ECL2 worked with our general contractor, designing the manufacturing and warehousing space, worked with Sheri Gay, the President of Aero-Med Medical to establish operations and hire the right personnel, took care of our regulatory requirements, implemented a new quality system, trained personnel and even acted as a liaison with our current and prospective client-base as we expanded our operation. - Dan Del Mastro, Chief Executive Officer, Aero-Med Ltd.
