One of the fastest growing areas of need today is for meeting quality system regulations for the performance of both internal audits and audits of critical vendors and suppliers. As a result of an increasing number of companies contracting out manufacturing and filling processes and the dependence on suppliers for everything ranging from raw materials to services, VTS Consultants is routinely called upon to help meet these requirements. These audits help to identify internal cGMP deficiencies along with assuring that vendors have quality programs designed to deliver the products or services required. VTS Consultants not only summarize deficiencies found during quality audits performed, but we also provide the client with recommended corrective actions to implement for their resolution.
In addition to auditing services, VTS Consultants can assist clients with regulatory submission documents and pre-approval inspections. Our quality group, which includes some former FDA inspectors, can help provide responses needed to address regulatory observations or warning letter issues.