When the Experts Need Help, They Call Our Clinical Team

When the Experts Need Help, They Call Our Clinical Team

We offer a wide variety of services to pharmacies to assist in compliance with USP <797>, <800>, <823/825> and with FDA 503A and B pharmacy programs. We review your: Pharmacy engineering and administrative controls; Operations; Behaviors and practices of compounding personnel; Environmental conditions and monitoring; Labeling and storage procedures; and a number of other areas that are critical for the proper compounding of sterile preparations and patient, as well as, personnel safety. Our team of compounding experts will work with you to review your existing cleanroom workflows and develop a complete set of Pharmacy Compounding Standard Operating Procedures to ensure compliance with USP <797> ,<800>, and <823> (if applicable), FDA and the FDA Sections 503A and B, and State Boards of Pharmacy. Our team includes professionals with over 120 years of combined experience in the field of GMP and GTP cleanroom design, construction, commissioning, qualification, and operations. We have extensive knowledge of the Code of Federal Regulations, as well as HCT/P compliance and Quality Systems regulations in the U.S. and EU. Our biologics experts have a complete understanding of GMP and GTP regulatory requirements, and works closely with scientific staff to understand their processes and help transfer them into the GMP manufacturing phase and then into the clinical setting.