Does McGuff Pharmaceuticals have adequate depth in process science to ensure high-quality development and/or troubleshooting of problems encountered in process development, scale-up and/or validation.

YES!  Manufacturing operations, combined with well-established Standard Operating Procedures (cGMP and ISO 9001:2000 certified), Training, Validation and Testing systems, provide a cohesive regulatory compliance environment.  This merging of organization, facilities and regulatory focus supplies a quality product satisfying the cost-consciousness and timely delivery expectation of our customers and Outsourcing Sponsors.

Can McGuff Pharmaceuticals handle the transition from phase III to commercial qualification lots and commercial launch?

YES!  If we commit to phase III clinical trails to commercial qualification and commercial production we will assure our customer favorable scheduling, manufacturing and product flexibility, intelligent resource allocation, and regulatory compliance.

Does McGuff Pharmaceuticals provide adequate support and a defined approach to program management and communication with clients?

At McGuff Pharmaceuticals, we listen to you first.  Success of any outsourcing project depends on a close, flexible relationship between both parties at the highest levels to achieve mutual success.   We have a proven capability of developing a process that is robust, transferable, and scalable to meet the clinical trial requirements through commercial manufacturing needs of our sponsor.