Meridan Consulting

Meridan Consulting is a New Jersey-based consulting firm specializing in services for the pharmaceutical industry. Founded in 2001 by Elyse Smith, a former FDA Consumer Safety Officer, the company has grown to over 50 consultants, many of whom are also former FDA Investigators. Meridan Consulting assists pharmaceutical companies in obtaining FDA site approvals and maintaining compliance throughout new product introductions. Their services include representing clients to the FDA, responding to FDA-483 observations, Warning Letters, and Notices of Import Alert. The company's team of consultants possesses diverse expertise ranging from product development to regulatory affairs, enabling them to evaluate facilities, file product applications, and provide tailored advice for successful inspections. Beyond providing guidance, Meridan Consulting identifies potential areas of concern and offers specific remediation strategies. Their proven track record demonstrates their commitment to helping clients achieve FDA compliance and secure product approvals. Meridan Consulting is a certified Women’s Business Enterprise by the Women’s Business Enterprise National Council (WBENC). For more information, please visit meridanconsulting.com.