Audits and Assessments

Strategic Planning for FDA Facility Approval

Meridan works with companies in the early stages of facility and quality system design which enables companies to proactively address any potential compliance concerns. Proactive identification and remediation of compliance issues is critical to ensuring a successful outcome and speedy facility approval.

Meridan Consultants not only provide expert feedback on facility and quality system design, but provide expert guidance on how to address any gaps between operations and regulatory expectations.

Pre-approval Inspection Audits

Meridan has consultants with extensive domestic and international experience in conducting pre-approval audits of all dosage forms. Conducting a pre-submission review confirms that your application is ready for filing. Filing an application and opening yourself up to FDA scrutiny before you are ready is a critical error that you want to avoid at all costs. An independent assessment of your data and supporting systems should be considered a standard step in your product application and approval process.

Vendor and Service Provider Audits

Vendors and service provider audits are critical components of a company’s quality system. Meridan routinely conducts vendor and service provider audits on behalf of firms to assess the vendor’s facility, integrity of data, quality systems and adherence to written procedures and quality agreements. Our experienced team focuses on the critical areas of assessment to aid clients in understanding if there is any supply risk associated with their vendors and service providers. Our talented team of auditors are second to none.

Due Diligence Assessments

To make informed decisions during mergers and acquisitions it is critical to have all the facts available to the due diligence team. When determining if a company is an appropriate fit with your business goals and objectives, it is critical to assess the target company from a compliance risk perspective. A due diligence assessment is much more than an audit. It is a comprehensive assessment of the target company’s organization, their effectiveness, their facility, quality systems and compliance risks. Meridan has been participating as a member of due diligence teams for many years, and has a proven track recording of providing companies with compliance risk-focused insight that aids the team in making the most informed decisions possible.