Business Strategy Support
Kapstone can partner with your commercial team to help you develop a proactive business strategy that integrates the needs, opportunities, and resources required to help achieve your goals. Kapstone’s seasoned experts have started up and run commercial product-based companies, so we know what it takes to initiate launch activities but also to scale up in a capital-efficient manner. Our process considers business needs from all angles.
Market Entry Support
Kapstone is an ISO-certified and FDA-registered company that assists with key regulatory aspects of launching your product, importation requirements, and U.S. Representative services - all designed to leverage our expertise and single-source philosophy for your benefit. Whether you are U.S.-based entity or seeking to enter the U.S. market for the first time, we assist with market entry requirements and best practices to ensure a smooth product launch. There are a myriad of regulatory, quality, financial and operational factors to consider, and Kapstone can help ensure that the process is efficient and effective.
Product Launch Support
Knowing how and when to launch your product is often as critical as the product itself. We have helped launch dozens of new products - from single-use surgical kits to home-based therapeutic devices - by assisting our clients with product and process readiness activities including design transfer, inventory build, regulatory compliance and operational support. With our breadth and depth of experience, we are ideally suited to you with establishing your strategic launch plans. And it doesn’t stop with a commercialization event; Kapstone continues to support limited and full launches with ongoing activities in all of our main service areas.
Incubation & Ongoing Operational Support
We provide services in all of the key functional back office areas that a company needs early on - including Engineering, Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Logistics and Distribution, and Operations. Consider Kapstone your bridge from startup to building out your internal staff. You can take time with important hires to make sure that you have the right people and processes in place for effective scalability.