We understand that compounding pharmacies are under constant pressure to deliver the highest product quality to ensure patient safety while meeting business objectives. Our team members are experts on the interpretation of USP <797> and <800> guidelines for 503A pharmacies and CGMPs for outsourcing facilities. Through our collaborative relationship with the FDA and industry organizations, we are on the cutting edge of regulatory hot topics surrounding aseptic processing. We have a proven track record of helping 503As and 503Bs achieve regulatory compliance through design reviews, facility gap assessments, mock regulatory inspections and guidance on corrective actions.
Our team of technical and operational experts consult and collaborate with biopharmaceutical companies and compounding pharmacies throughout the world in the areas of CGMP regulatory compliance, as well as aseptic facility design, construction, validation, and master planning. We deliver timely, cost-effective and compliant solutions to the most perplexing regulatory challenges.
Featured Compounding Pharmacies Experts
Sr. Compliance Consultant/Sr. Vice President Compliance
Komal Hatti, NCARB, MBA
Director, Process Architect
Sterling G. Kline, RA
Aseptic Subject Matter Expert
Joanne Meloro, ASQ CQA
Director, Strategic Initiatives
Mark E. Rezac, PE
Director, Compliance Services