Orthopaedic Regulatory Clinical Associates, LLC (ORCA) was established to meet the needs of companies in the Orthopaedic Industry, both large and small. Our team of experts has decades of real-world hands-on experience with medical devices, biologics and pharmaceuticals, and has also worked with combination products. ORCA is committed to achieving your business goals, whether increasing the valuation of your company for an exit strategy or designing a clinical trial that will simultaneously collect data for an FDA approval as well as for reimbursement. ORCA's model is to review the company's business goals then to analyze and formulate a program customized to your needs to successfully complete your US FDA registration process. Our Senior Regulatory and Clinical Management Team has over 70 years of combined experience and success in obtaining FDA approvals from CDRH, CBER and CDER. The benefit of our vast experience is not only achieving FDA Approvals but also incorporating reimbursement data into your clinical trials making them more efficient and cost-effective. |
