Keep your pharmacy up-to-date with Destry Sillivan’s detailed mock facility inspections. At T Cubed Regulartory Consulting in Bowie, Maryland, Destry provides an array of services to ensure your company’s success, including official regulatory submission audits.
Facility Design Review
To help you meet necessary FDA requirements, Destry Sillivan performs an overall inspection of your company design. All manufacturers need this inspection and will benefit from his keen attention to detail. Before you start building your new facility, order Destry’s complete consultation services, which include design, validation activities, mock inspections, and more. He has all the experience needed to carry out a thorough review of your facility design.
Facility Mock Inspections
Prior to FDA inspections, Destry Sillivan makes sure that your company is fully prepared. He inspects the full facility, including all aspects of the facility design.
Throughout the life cycle of your company and any time you are studying a drug in humans, you are required to have regulatory submissions audits for approvals or post marketing. For example, if you want to change a manufacturing machine, you must submit written communication with the FDA. Destry Sillivan can help speed along this time-consuming process by auditing your submissions.