ORCA represents clients world-wide, helping those companies successfully register their products for sale in the United States. Some of our clients are based in:
This is just a partial list and we continue to sign new clients. ORCA is registered with FDA as a US Agent. This allows us to represent your company to FDA for non-business communications. All non-US companies are required to have a representative to facilitate communications between the company and FDA. ORCA's trained professionals will guide you through the unfamiliar process of US FDA Regulations. Our practice is to evaluate your company's existing information, procedures and goals and then proceed to craft a strategy for successfully taking your product through the FDA Approval process. This process is significantly more efficient and substantially more cost effective for your company. |
