An Ally in Compliance. A Partner in Quality.

An Ally in Compliance. A Partner in Quality.

FDA Compliance Consulting

About Us

FDA Global Compliance Elite is a growing network of former FDA Investigators and product reviewers with experience to provide an elevated level of expertise in FDA regulatory compliance and strategy, quality systems review, and planning in all GMP, GCP, GTP, and QSR environments. Our former-FDA consultant affiliates have no less than 15 years of direct FDA employment, performed hundreds of client audits and/or regulatory inspections, successfully helped clients navigate the BLA process to approval, mitigated FDA regulatory action, and provided onsite inspection and quality assurance support, as well as training. This provides our clients all over the globe with a high level of regulatory expertise required to achieve a successful outcome. We have served, and are trusted by, all FDA regulated industries, including:

  • Biologics

  • Bioresearch Monitoring

  • Blood and Plasma Products

  • Medical Devices

  • HCT/P

  • Cellular Therapy

  • Pharmaceuticals

  • Dietary Supplements

When asked about the current state of compliance consulting, Ms. Scott stated, "Currently, even regulatory agencies are recommending that Industry seek expert consultants where significant inspectional observations have been documented. It's very frustrating for clients to waste time, effort, and money on a consultant that was put forward for a project simply based on their calendar availability, as opposed to their expertise. We believe that giving you the right expert the first time is a better way to do business." She added that, "this is a client-driven business and the first consideration should be the skill set required to fulfill the client need. If I don't have the relevant expertise for the project, I'll turn to the network to find a consultant that does."

FDA Global Compliance Elite, LLC, is not a checklist operation. That is to say, our consultants aren't going to arrive onsite for an audit, simply to check off the boxes in order to document that they verified the existence of required systems. We are going to critically evaluate the relevant systems, upstream-to-downstream, from SOP development to implementation, and to ascertain the functionality of quality oversight, and we will employ our FDA-trained methods to do so. To do any less would be a disservice to the client and a waste of budget. Our goal is to provide clients with the expertise they need, efficiently and cost-effectively."