Regulatory Affairs & Quality Management

Avenue’s ability to achieve all activities “in-house”, in a strictly controlled environment (Class 8 cleanroom) ensures its customers get their products to market faster and with complete confidence.

All products are manufactured in compliance with current GMP requirements laid down by the FDA Code of Federal Regulations 21 CFR820 and European GMPs ISO 13485:2003 and ISO 9001:2008.

Avenue continually seeks to achieve the highest level of quality and efficiency to match, or exceed customers’ expectations on delivery and responsiveness.

Our operating philosophy is one of continuous improvement and all employees direct their efforts towards ensuring the Quality Management System is effective and operates at all times in full compliance with the requirements of I.S.EN ISO 13485:2003.

The employees at Avenue Mould Solutions are committed to the philosophy of Avenue becoming the “Outsourcing Partner of Choice” for our customers.