S. W. Hatfield

S.W. Hatfield & Associates is a specialized consulting firm that provides quality assurance and regulatory compliance services to the global life sciences industry. The company specializes in GXP auditing, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) to ensure adherence to international regulatory standards. Their services include mock regulatory inspections, quality system development, and vendor audits for pharmaceutical, biotechnology, and medical device companies. They also offer specialized training and support for FDA inspection readiness and remediation efforts. By leveraging deep industry expertise, the firm helps clients mitigate risk and maintain high-quality standards throughout the product lifecycle.