Regulatory Submission Outsourcing
Octagon is well-known and highly regarded as the industry’s premier provider of Regulatory Submission Outsourcing Services. Our excellent reputation is important to us and we guard it closely by providing a unique blend of Regulatory Affairs AND Regulatory Operations support through all of our outsourcing models. We also utilize ViewPoint®, Octagon’s enterprise submission process management solution, to offer these services through a secure, controlled, process management platform for customers who are interested in taking advantage of our expertise and our technology. Our integrated sourcing offerings combine our outsourcing offerings with varying levels of access to ViewPoint, depending on your current needs and future goals. No matter whether you are a small start up or a large pharmaceutical company, we have the Regulatory expertise to manage, compile, quality check, publish and maintain your regulatory submission.
Each regulatory outsourcing project includes a knowledge transfer component. We will help you to become proficient at electronic regulatory submissions and/or global submission requirements. Our staff will make sure you understand the “why” behind what we do so that your organization’s outsourcing investment also adds to your organizational understanding of current electronic submission standards.
Clients come to us for our expertise in compiling original applications. They often stay with us to manage their entire submission lifecycle. Our Submission Stewardship Program provides Octagon’s Regulatory expertise and capacity throughout the submission lifecycle. This program was designed for small companies with minimal Regulatory and submission resources but it has also been utilized by growing and large companies to augment current staff.
- We are not a high volume conversion vendor; we are a full source submission partner
- We are not a technology vendor with limited industry experience; we are a trusted partner to some of the industry’s most competitive companies
- We are not a Regulatory Operations vendor; we are an integrated Regulatory Affairs and Regulatory Operations partner
Our Regulatory Services are the most emulated in the industry. Don’t Compromise.
|
