The GENEWIZ Regulatory Quality Management System ensures GLP, GCP and CLIA compliance throughout our preclinical and clinical projects. Quality oversight confirms strict FDA and EPA regulatory adherence for our regulatory services customers and consistency in all of your data.
As a trusted partner for research advancements and product development, we constantly strive to meet the needs and expectations of our customers. Our philosophy is to ensure that quality is built into all aspects of our regulatory services.
The Quality Management System for regulatory services is designed in accordance with CAP standards, FDA, EPA Code of Federal Regulations (CFR), and guidelines under European Medicines Agency (EMA). Our offers:
Our regulatory services lab at our South Plainfield, NJ headquarters is CLIA-licensed and CAP-accredited.
Designed in accordance with the FDA and EPA Code of Federal Regulations (CFR), the GENEWIZ Quality System is compliant with 21CFR, Part 58 as well as 40CFR, Part 160. To request an audit for regulatory services: