Oberhauser Consulting LLC

Oberhauser Consulting LLC delivers value by driving strategy creation and tactical execution in the development and commercialization of medical devices, drug delivery devices, and other combination products. OC also offers executive leadership support leveraging experience building and leading a device, package, and sterile process development function at a Fortune 500 pharmaceutical company. The keys to client success are: 1. Always keeping the needs of the product user top of mind 2. Adopting a product system perspective that appreciates the interactions between drug formulation, container closure system, delivery system, and packaging 3. Balancing risks and benefits in product development decision-making with an enterprise mindset Key focus areas for services include the following and many others: • Product development strategy • Supply chain network strategy • Executive leadership • Device quality system development • Device and container closure system selection • Packaging and labeling system development • Design control execution • Controlled release system development • Manufacturing process development and scale-up • Product characterization planning and execution • Design verification and validation • Global regulatory submissions • Clinical and commercial launch readiness • Product innovation • Lifecycle planning • Device-related diligence support Let Oberhauser Consulting LLC meet your combination product needs.