Regulatory Affairs Support

 
 
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Regulatory Affairs Support

We provide 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 ensure that investigational, marketing, and post-approval applications are compliant with these stringent regulations.

We offer 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:

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

Contact Us

For more information about our business solutions and capabilities, contact us today.