Always Be Inspection Ready

Meridan Consulting is a global regulatory compliance consulting firm for FDA-regulated industries. Meridan Consulting is owned and operated by a former US Food and Drug Administration (FDA) Investigator.

The company consists of former FDA Investigators and industry experts with experience ranging from product development to data integrity to regulatory affairs. Our team is uniquely qualified to assess your company’s facility, file your product applications and provide specific direction to facilitate 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 correct and respond to FDA-cited deficiencies, obtain an acceptable FDA compliance profile and product approvals.

Meridan specializes in investigation of data integrity breaches, development and execution of remediation programs. We have served as the consulting company of record to FDA for multiple foreign firms placed under Import Alert and we have independently assessed and certified hundreds of exempted finished product batches. Meridan has successfully executed remediation and certification programs where the outcome for the client was release from the Import Alert or lifting of the Warning Letter.