Regulatory Liaisons, LLC is a consulting organization that provides our clients with customized Regulatory
Affairs and Quality Systems services. We interface directly with our clients to provide them with the particular
services they need at the time they need them. We assist in your taking medical products from the point
of conception to research and development activities, provide design control support, promote compliance with quality system
and regulatory requirements for clinical trials and pre-market activities, ensure readiness for introducing your product to
the market place and post-marketing activities. Types of products we work with include prescription and OTC pharmaceuticals,
biologics, cosmetics, and medical devices, including IVDs, and combination products.
prepare you for marketing your products, we author Standard Operating Procedures and other supporting documentation to demonstrate
compliance with the requirements for a company regulated by the United States Food and Drug Administration. Having assisted
you with the authoring of your premarket submissions to the FDA or other regulatory bodies, we prepare clients for initial
and routine licensing, certification and registrations with State, Federal, and International regulatory bodies. We train
your employees in an engaging and memorable manner to ensure employees understand their responsibilities related to developing
and marketing medical products. Conducting routine Good Manufacturing Practices and Good Clinical Practices audits to promote
compliance with the ever-evolving regulatory requirements is among our areas of expertise.