Quality and Regulatory Compliance

Leidos offers significant expertise in quality and regulatory compliance. We assist customers in assuring that their production facilities apply industry best practices and are in compliance with stringent U. S. Food and Drug Administration (FDA) and international regulatory requirements. Our team of regulatory and quality experts includes former industry and FDA scientists and inspectors who have extensive knowledge of pharmaceutical, biologic, and medical device manufacturing and testing requirements and standards.

Supporting customers globally, Leidos performs comprehensive pharmaceutical manufacturing and testing facility audits and assessments to help identify potential process deficiencies, and take corrective action prior to regulatory agency inspections.

We develop, implement, and manage compliance strategies for pharmaceutical, biologic, and medical device manufacturers to help assure proper procedures are in place.

We advise and train customers on current Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP); we help our customers write and review vendor qualifications and validation protocols for completeness, in accordance with regulatory guidelines; and we perform mock inspections and assess facility qualifications worldwide to facilitate manufacturing and product quality.

Our quality and regulatory compliance support services include:

Quality and Regulatory Compliance Services

Service	Benefit
Quality systems auditing	Greater assurance of compliance and clear direction for corrective actions
Regulatory gap and risk analysis	Early risk mitigation and identification of deficiencies
Validations and qualifications	Validated systems and qualified equipment that conforms with regulations
Quality program development	Documentation that stands up to regulatory authority scrutiny
Training	Knowledgeable, quality-driven workforce