Managing Product Development and Clinical Supplies

Through our deep understanding of the challenges facing global Pharmaceutical Product Development and clinical supply we are able to:

• Develop and implement global strategies to manage the development and supply of products for Phase II, Phase III & Phase IV clinical trials.
• Manage the formulation development for products from Phase I through to commercialization including analytical method development, stability testing and technology transfer.
• Provide novel approaches to clinical supply packaging and labeling that assures the highest product control and integrity, and maximum patient compliance to the study regimen.
• Identify potential obstacles and solutions to the successful execution of a global supplies distribution plan, including import/export, QP release, specialized storage, and shipping.
• Identify and manage reliable qualified CRO’s and CMO’s with the development and supply of all major dosage forms, including novel drug loaded devices.