Regulatory Operations
Play to your strengths... and ours.
With over 60 resources, Octagon's Regulatory Operations team offers the largest collection of regulatory submission professionals in the industry. Our teams are thoroughly trained on electronic submission guidances, industry tools, emerging standards and Octagon best practices. Our submission process expertise is unmatched:
- Each submission manager has produced multiple original new drug submissions
- We have successfully completed and delivered seven simultaneous electronic new drug applications to the US FDA in the same week
- We have never missed a submission deadline
- We have never received a refuse-to-file
Our Regulatory Operations team works closely with Regulatory Affairs, Clinical Information Management and Quality Assurance to ensure a compliant deliverable. We communicate with sponsors frequently throughout the project to make certain that they understand the project status. In addition, we provide access to the ViewPoint® Reviewer that enables sponsors to review and address any identified issues in real time. Our submission managers develop tight integration with sponsor teams, manage the specialized technical expertise required for evolving submission formats and facilitate all aspects of submission planning and production. We remove traditional functional barriers to inspire the confidence of our sponsors in our quality processes and the resulting products.
Whether you are looking for short-term assistance or a longer-term outsourcing partner, Octagon's Regulatory Operations group delivers submissions.
