Regulatory Affairs Support

Leidos provides comprehensive regulatory affairs consulting services to foster the submission and approval of accurate, scientifically sound regulatory documents.

Our regulatory affairs professionals apply their expertise in the development of drugs, vaccines, biologics, therapeutics, and medical devices. Their keen understanding of the U.S. Food and Drug Administration (FDA) and international regulatory agency requirements helps assure that investigational, marketing, and post-approval applications are compliant with these stringent regulations.

Leidos offers a wide range of services, including regulatory strategy and planning assistance; regulatory authority interaction guidance; document preparation and control; transition from paper to electronic submission; and non-clinical and clinical protocol development and review.

We collaborate with our customers to assist them in navigating the complex regulatory pathway from research and development to clinical trials and licensure. Leidos staff provides critical regulatory guidance at every step of the product development process, helping to accelerate time to market for drugs, vaccines, biologics, and devices.

Our regulatory affairs services include:

Regulatory Affairs Support Services

Service	Benefit
Regulatory affairs consulting	Clear regulatory path-forward with sound solutions
Regulatory compliance support	Compliant regulatory submissions
Document preparation and control	Assurance that regulatory documents are prepared accurately and expeditiously
Product development plans	Sound integration of all needs resulting in more rapid development
Training	Greater understanding of regulatory requirements