Specializing in consulting services for the pharmaceutical industry, this New Jersey-based company was founded in 2001 by Elyse Smith, a former FDA Consumer Safety Officer (Investigator) from the New Jersey District. The company consists of over 50 consultants, many of whom are former FDA Investigators, all of whom were individually selected by Elyse based on experience and area of expertise.
The company was founded with the goal of helping companies to “Always Be Inspection Ready”. Since its inception the company’s focus has been on assisting firms to obtain FDA site approval and maintain compliance throughout new product introductions. Meridan represents clients to FDA and has a long-standing history of helping companies to successfully respond to FDA-483 observations, Warning Letters and Notices of Import Alert.
Our pharmaceutical consultants have experience ranging from product development to regulatory affairs. Our team is uniquely qualified to assess your company’s facility, file your product applications and provide specific direction that promotes a successful inspection outcome. We not only identify potential areas of concern, but also provide specific advice on how to remediate. Meridan Consulting has a proven track record when it comes to helping firms obtain an acceptable FDA compliance profile and product approvals.
Meridan Consulting is certified as a Women’s Business Enterprise by the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women in the U.S.