Guidance in Expanding Offerings with Value-Added Services subject to FDA requirements as well as Distribution Requirements
We can help you navigate through those requirements to establish a kitting operation or to understand your requirements in regards to labeling which includes any additional inserts, brochures, etc. If you just need help in understanding your requirements as a distributor in the FDA-regulated supply chain we assist you also.
Compliance Auditing Services
Our auditing services will allow you to quickly identify where your gaps exist. We can provide you with a comprehensive gap analysis including identifying gaps with your inventory management system.
System Validation when Distributing Product Subject to these Requirements (pharma, med device, bio-tech, food…)
If we do identify gaps in your system, we can help you with those as well as creating specification documentation required for validation and perform the validation services for you.
Inventory Management System Selection
If you need assistance in finding a system to support your regulated activities we can help with that as well. We have combined expertise in distribution operations as well as regulatory requirements.
Equipment Commissioning (coolers, freezers, trailers used to store or transport temperature-controlled product, etc.)
Limiting your liability with regards to product integrity as well as complying with regulations is critical. ECL2 offers commissioning as well as qualification for all of your storage areas.
ECL2 has extensive expertise when it comes to creating procedures as well as developing training to support those new standard operating procedures.
Automated Quality Management System Set-up
ECL2 also works with customers to find the right distribution solution for their pharmaceutical, biotech, medical device and food service needs.