Quality Assurance & Regulatory

As your project is defined, members of Lifecore’s Quality Assurance and Regulatory departments join the team to support the project and ensure that the elements of the quality system are being met and that elements of the regulatory approval process are assessed and anticipated through each stage of clinical development in various markets.

The entire Lifecore team is committed to patient safety by complying with applicable standards, regulations and statutory requirements through Lifecore’s established quality system.

Lifecore’s quality system is compliant to the following:

• 21 CFR 820 (FDA Quality System Regulation)
• 21 CFR 210, 211 (FDA Good Manufacturing Practice)
• EudraLex Volume 4 (EU Good Manufacturing Practice)
• EN ISO 13485, Medical Devices – Quality Management systems – Requirements for regulatory purposes
• Consolidated European Medical Device Directive 93/42/EEC
• ICH Q7, GMP Guide for Active Pharmaceutical Ingredients

The QA and Regulatory staff manage client and regulatory audits during all phases of development and ensure compliance with the US and EU as required by the projects.