Katrina Rogers Consulting is committed to helping people change the world. We help people by finding astute solutions to their business problems. We are management consultants with a focus on medicines and medical devices.
We believe that there are people out there with big ideas, ideas that can change the world. These people dream of a medical device or medicine that will have a positive impact. The problem is they are stuck. Whether it’s problems with their idea, their process, their business, or regulations, they need help getting to the next stage.
Our team understands the regulations, science, and technology behind your medicine or medical device. We can assess your current and future stage gates and the data you need to meet your next financial or regulatory milestone. Medical product development is a long game, and we are here to provide astute solutions to move your medical products from bench to bedside.
Katrina Rogers Consulting was founded by Katrina Rogers who is a change expert with over 24 years of experience in the discovery, development, and manufacture of medicines and related technology. An expert in laboratory and technical operations, she is also an ASQ Certified Manager of Quality/Organizational Excellence and Pharmaceutical GMP Professional. Her professional services firm specializes in dramatically decreasing the cost and time of bringing new therapies to the market.
Developing a medical product requires an understanding of the business and regulatory processes. A clear picture of the development pathway for your product will allow you to set goals, measure progress, and mitigate risk. We are experts in pharmaceutical and medical device business and regulatory strategy. We evaluate your product for feasibility, outline a structure of development stage gates, and identify the requirements to complete each stage. Our experience with discovery/preclinical development, analytical laboratory operations, and chemistry, manufacturing, and controls (CMC) gives you a broad perspective on your products’ current and future needs.
Modern medical products companies make considered choices on what parts of their operations must use in-house expertise and what can be effectively outsourced. Cost is not the only consideration; the novel science or technology of your product will present unique business and regulatory risks that require an adaptive approach to operations.
Planning and developing a new medicine or medical device requires a coordinated leadership team capable of balancing their strengths and learning new skills, especially as your business scales. We provide objective assessments for your executive personnel, recommendations for individual and team growth, and custom training and coaching to enhance skills and team cohesion.